Recalls today

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230

Quantity: 689

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-0226-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

MEDLINE medical convenience kits labeled as: (list truncated)

Quantity: 146971 kits

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

Recall number Z-0278-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300

Quantity: 3284

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-0233-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810

Quantity: 658

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-0259-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340

Quantity: 748

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-0237-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240

Quantity: 8542

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-0227-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly

Quantity: 14210 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-0194-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030

Quantity: 56,331 (US); 40,211 (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-0267-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840

Quantity: 7945

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-0260-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

ROTOR ASSY-SW40, Reference Number 331302, 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: 92 units

Distribution: US Nationwide distribution.

Recall number Z-0201-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Techno-Path Multichem AE Unassayed Level 2 REF: AE622X

Quantity: 123 units

Distribution: US Nationwide distribution in the state of Massachusetts.

Recall number Z-0206-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " Simplera sensor " Instinct sensor " InPen smart insulin pen " Apple Watch [Optional] Continuous glucose monitoring (CGM) is a technology that allows you to continuously view glucose values. The app uses an inserted Simplera sensor CGM or Instinct sensor CGM with Bluetooth¿ wireless technology that converts small amounts of glucose from the interstitial fluid under the skin into an electronic signal. The sensors use that signal to provide sensor glucose (SG) values to the MiniMed Go app on a compatible mobile device. The app also provides alerts based on your SG levels and contains a user interface for entering data such as insulin, meals, exercise, blood glucose (BG) values, and uploading information to the CareLink" Personal website. The app is available to download from the Apple"* App Store"* or the Google Play"* Store. Component: No

Quantity: 623

Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, CA, CT, FL, LA, MA, MD, NY, OH, PA, and TX. The countries of Austria, Belgium, Denmark, Finland, Germany, Iceland, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom.

Recall number Z-0265-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)

Quantity: 860450

Distribution: U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.

Recall number Z-0200-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.

Quantity: 180 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0131-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

MEDLINE medical convenience kits labeled as (list truncated)

Quantity: 26965 kits

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

Recall number Z-0275-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly

Quantity: 476,256 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-0196-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260

Quantity: 358

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-0229-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.

Quantity: 30,120 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0132-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.

Quantity: 56 kits

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

Recall number Z-0281-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly

Quantity: 3746 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-0197-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.

Quantity: 100 units

Distribution: Distribution US nationwide including Puerto Rico.

Recall number Z-0127-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280

Quantity: 381

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-0231-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer

Quantity: 16

Distribution: US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.

Recall number Z-0211-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750

Quantity: 432

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-0258-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440

Quantity: 620

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-0243-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

Quantity: 42

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-0232-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-519-35, Item # 88519, UPC 8 10147 88519 0

Quantity: 112,092 tubes

Distribution: US Nationwide.

Recall number D-0063-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3

Quantity: 797,868 tubes

Distribution: US Nationwide.

Recall number D-0065-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-003-40, Item # 32731, UPC 8 50048 32731 3

Quantity: 320,232 tubes

Distribution: US Nationwide.

Recall number D-0055-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10

Quantity: 134 1000-count bottles

Distribution: US Nationwide and Puerto Rico

Recall number D-0051-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.