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Updated 3 minutes ago · U.S. FDA

Medical devices recalls

Everything from test strips and syringes to pumps and implants. New recalls appear here every day, explained in plain English.

Counts are for the last 30 days.

In the last 30 days the FDA announced 201 medical devices recalls. Over the last 90 days the most common cause was device fault or failure (135 recalls). 48 of the 565 FDA recalls in that period were Class I, the most serious kind.

New Medical devices recalls per weekLast 8 weeks
150100500
Sep 14
Sep 21
Sep 28
Oct 5
Oct 12
Oct 19
Oct 26
Nov 2
Show as table
Week ofMedical devices
Sep 1420
Sep 2188
Sep 2856
Oct 5136
Oct 1251
Oct 1958
Oct 2692
Nov 20
Why products were recalledLast 90 days, grouped from the official recall reasons
Device fault or failure135 recalls
Contamination (mold, bacteria, other)98 recalls
Labeling or packaging error90 recalls
Not sterile40 recalls
Fall or injury hazard14 recalls
Manufacturing quality (cGMP)7 recalls
Wrong strength, impurity or failed test6 recalls
Fire or burn hazard4 recalls
Other168 recalls
Show as table
ItemValue (recalls)
Device fault or failure135
Contamination (mold, bacteria, other)98
Labeling or packaging error90
Not sterile40
Fall or injury hazard14
Manufacturing quality (cGMP)7
Wrong strength, impurity or failed test6
Fire or burn hazard4
Other168
How serious were the FDA recalls?Last 90 days
Class I — most serious · 48Class II · 506Class III — least serious · 11
Show as table
PartCountShare
Class I — most serious488%
Class II50690%
Class III — least serious112%

Class I: Most serious: using the product could cause serious injury or death. Class II: May cause temporary or reversible health problems; serious harm is unlikely. Class III: Unlikely to cause harm, but breaks FDA rules (for example a labeling error).

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Latest medical devices recalls

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710

Quantity: 609

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0255-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class I · Ongoing

VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Product details, where it was sold and what to do

VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.

Quantity: 4,369 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0122-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101

Quantity: 4765 units

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0269-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Techno-Path Multichem AE Unassayed Level 3, REF:AE623X

TECHNO-PATH MANUFACTURING LTD. · Ballina Tipperary, Ireland

Why: A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results t…

Product details, where it was sold and what to do

Techno-Path Multichem AE Unassayed Level 3, REF:AE623X

Quantity: 832 units

Distribution: US Nationwide distribution in the state of Massachusetts.

Recall number Z-0207-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210

Quantity: 2547

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0224-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class I · Ongoing

VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Product details, where it was sold and what to do

VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.

Quantity: 1,534 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0124-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330

Quantity: 206

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0236-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3) OB/GYN, Medline Kit Number/SKU DYNJ911652.

Quantity: 2229 kits

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0276-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class I · Ongoing

V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Product details, where it was sold and what to do

V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.

Quantity: 25,112 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0133-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class I · Ongoing

V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Product details, where it was sold and what to do

V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used for ventilatory support.

Quantity: 39,568 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0129-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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Medical devices · Oct 28, 2026 · Class II · Ongoing

InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A1…

Medtronic Neuromodulation · Minneapolis, MN, United States

Why: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.

Product details, where it was sold and what to do

InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSMRI TINED 978B128 LEAD 978B133 ISTM II 33CM SSMRI TINED 978B133 LEAD 978B141 ISTM II 41CM SSMRI TINED 978B141

Quantity: 94,441 (US); 60,488 (OUS)

Distribution: Worldwide distribution - US Nationwide and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Ireland, Netherlands, Iceland, Denmark, South Africa, Turkey, Slovakia, Saudi Arabia, Poland, Hungary, United Arab Emirates (UAE), Kuwait, Greece.

Recall number Z-0266-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Xact mole marker for mammography Model/Catalog Number: M15RM

Solstice Corporation · South Portland, ME, United States

Why: The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.

Product details, where it was sold and what to do

Xact mole marker for mammography Model/Catalog Number: M15RM

Quantity: 736

Distribution: Worldwide - US Nationwide distribution in the states and territory of CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and Puerto Rico. The country of Canada.

Recall number Z-0268-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320

Quantity: 632

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0235-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270

Quantity: 1912

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0230-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUDYNJ908124B.

Quantity: 233 kits

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0274-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: …

restor3d Inc. · Durham, NC, United States

Why: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

Product details, where it was sold and what to do

Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, single-use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace the damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement. The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished. Component: Not a component

Quantity: 16

Distribution: U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.

Recall number Z-0264-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens

CooperVision, Inc. · West Henrietta, NY, United States

Why: The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.

Product details, where it was sold and what to do

Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged.

Quantity: 230856

Distribution: US Nationwide distribution in the states of FL, KY, MI.

Recall number Z-0204-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108

Quantity: 2569 units

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0271-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650

Quantity: 860

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0252-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850

Quantity: 926

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0261-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480

Quantity: 45

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0246-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A

Quantity: 222 units

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0273-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640

Quantity: 3145

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0251-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G

Quantity: 3 kits

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0279-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430

Quantity: 76

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0242-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Halyard ANTERIOR HIP PACK

AVID Medical, Inc. · Toano, VA, United States

Why: A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.

Product details, where it was sold and what to do

Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.

Quantity: 56 kits

Distribution: US Nationwide distributor in the state of Arizona.

Recall number Z-0282-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 …

Beckman Coulter, Inc. · Indianapolis, IN, United States

Why: Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.

Product details, where it was sold and what to do

ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471)

Quantity: 336 units

Distribution: US Nationwide distribution.

Recall number Z-0202-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-…

Abbott · Plymouth, MN, United States

Why: Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).

Product details, where it was sold and what to do

Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-0191-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106

Medline Industries, LP · Northfield, IL, United States

Why: Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Product details, where it was sold and what to do

MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106

Quantity: 161 units

Distribution: Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recall number Z-0270-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 28, 2026 · Class II · Ongoing

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510

Boston Scientific Cork, Ltd. · Cork, Ireland

Why: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Product details, where it was sold and what to do

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510

Quantity: 112

Distribution: Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Recall number Z-0248-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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What to do if you own a recalled product

  1. Match it exactly. Recalls usually cover specific lot or batch numbers, "best by" dates, model numbers or sizes. Compare every detail on your product with the notice.
  2. Stop using it. For food and medicine, do not eat, take or give it to pets, even if it looks and smells fine: Listeria and Salmonella do not change how food looks.
  3. Follow the remedy. Most recalls offer a refund, repair or replacement. Return food to the store or follow the company's instructions; for products, contact the company named in the notice.
  4. Do not stop a prescription medicine on your own. Ask your pharmacist or doctor first. They can swap you to an unaffected batch.
  5. Report problems. In the U.S., report illnesses from food or medicine to FDA MedWatch and injuries from products to SaferProducts.gov.

Beware of recall scams

Criminals send fake "recall refund" texts and emails that ask you to pay a "shipping fee" or enter card details. Real recalls never ask for payment. Paste any suspicious recall message into our scam text checker. Read more: Product recalls: how they work and what to do.

Sources: U.S. Food and Drug Administration Enforcement Reports (via openFDA) and the U.S. Consumer Product Safety Commission recall database. FDA enforcement reports list recalls when they are classified, which can be a few weeks after the company's first announcement. Vehicle recalls are available per vehicle in our VIN check.