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Every new U.S. recall of food, medicines, medical devices and household products, in one place, updated every day. Search for a product or brand you own.

Counts are for the last 30 days.

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Latest recalls

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

Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610

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/STRAIGHT/1RO/130; Material Number: M001195610

Quantity: 1212

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-0249-2027 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/STRAIGHT/1RO/155; Material Number: M001195620

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/STRAIGHT/1RO/155; Material Number: M001195620

Quantity: 598

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-0250-2027 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 (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. 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 (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.

Quantity: 606 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0125-2027 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

Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly

Medtronic Navigation, Inc. · Lafayette, CO, United States

Why: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

Product details, where it was sold and what to do

Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly

Quantity: 83,594 units

Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,

Recall number Z-0195-2027 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/STRAIGHT/1RO/105; Material Number: M001195400

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/STRAIGHT/1RO/105; Material Number: M001195400

Quantity: 39

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-0239-2027 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 (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. 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 (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.

Quantity: 325 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0123-2027 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 TRAY-LF, Medline Kit Number/SKU OBN471K

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 TRAY-LF, Medline Kit Number/SKU OBN471K

Quantity: 108 kits

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

Recall number Z-0280-2027 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/027/STRAIGHT/1RO/155; Material Number: M001195720

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/155; Material Number: M001195720

Quantity: 378

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-0256-2027 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: SOAH30.

Quantity: 80 kits

Distribution: US Nationwide distributor in the state of Arizona.

Recall number Z-0283-2027 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 Model Number: PRT-01100-000, Package PN:PRT-01126-000. 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 Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.

Quantity: 1,532 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0126-2027 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

Philips Smart-hopping 2.0 AP 1.4 GHz

Philips North America · Cambridge, MA, United States

Why: Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).

Product details, where it was sold and what to do

Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;

Quantity: 174

Distribution: US Nationwide distribution.

Recall number Z-0199-2027 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: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P

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: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P

Quantity: 10 kits

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

Recall number Z-0272-2027 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/027/BERN/1RO/130; Material Number: M001195740

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/BERN/1RO/130; Material Number: M001195740

Quantity: 1135

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-0257-2027 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

PNE Lead Implant Kit REF: 1701

Axonics, Inc. · Irvine, CA, United States

Why: Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Product details, where it was sold and what to do

PNE Lead Implant Kit REF: 1701

Quantity: 18,294 kits

Distribution: US Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI, SC, IL, NC, KY, VA, CO, KS, AZ, OH, MN, PA, ND, MD, OK, GA, AR, WI, TX, SD, CT, IN, LA, WA, OR, WV, MA, TN, MT, NJ, DE, ME, NM, IA, NH, MO, NV, MS, DC, ID, VT, WY, UT and the countries of United Kingdom & Australia.

Recall number Z-0198-2027 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/BERN/1RO/155; Material Number: M001195250

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/BERN/1RO/155; Material Number: M001195250

Quantity: 1292

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-0228-2027 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

B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP

B Braun Medical Inc · Bethlehem, PA, United States

Why: Potential for leakage and backflow at the Safsite valve.

Product details, where it was sold and what to do

B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.

Quantity: 461,300 units

Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand.

Recall number Z-0193-2027 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/SWAN/1RO/155; Material Number: M001195310

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/SWAN/1RO/155; Material Number: M001195310

Quantity: 486

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-0234-2027 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/130; Material Number: M001195500

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/130; Material Number: M001195500

Quantity: 1349

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-0247-2027 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

Think Surgical Square Driver REF: 109126

Think Surgical, Inc. · Fremont, CA, United States

Why: Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.

Product details, where it was sold and what to do

Think Surgical Square Driver REF: 109126

Quantity: 15 units

Distribution: US Nationwide distribution in the states of NY and DE.

Recall number Z-0192-2027 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/STRAIGHT/1RO/130; Material Number: M001195410

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/STRAIGHT/1RO/130; Material Number: M001195410

Quantity: 902

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-0240-2027 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) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O

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) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.

Quantity: 545 units

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

Recall number Z-0277-2027 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/155; Material Number: M001195220

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/155; Material Number: M001195220

Quantity: 459

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-0225-2027 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

VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. 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

VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.

Quantity: 4,368 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0128-2027 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

CareLink Clinic, REF: MMT-7350

Medtronic MiniMed, Inc. · Northridge, CA, United States

Why: CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator continues to use the syst…

Product details, where it was sold and what to do

CareLink Clinic, REF: MMT-7350

Quantity: 1

Distribution: US Nationwide distribution in the state of KS.

Recall number Z-0203-2027 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/105; Material Number: M001195200

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/105; Material Number: M001195200

Quantity: 126

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-0223-2027 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/STRAIGHT/1RO/155; Material Number: M001195420

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/STRAIGHT/1RO/155; Material Number: M001195420

Quantity: 228

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-0241-2027 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/BERN/2RO/155; Material Number: M001195350

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/BERN/2RO/155; Material Number: M001195350

Quantity: 384

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-0238-2027 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/027/BERN/1RO/130; Material Number: M001195940

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/027/BERN/1RO/130; Material Number: M001195940

Quantity: 550

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-0263-2027 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/027/STRAIGHT/1RO/130; Material Number: M001195910

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/027/STRAIGHT/1RO/130; Material Number: M001195910

Quantity: 86

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-0262-2027 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/155; Material Number: M001195450

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/155; Material Number: M001195450

Quantity: 357

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-0244-2027 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

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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.