FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Abbott Point Of Care Inc. — I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 6…Class II · 2012-03-01
Abbott Point Of Care Inc. — i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTn…Class II · 2012-02-01
Abbott Point Of Care Inc. — i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP t…Class II · 2012-02-01
Abbott Point Of Care Inc. — i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB…Class II · 2012-02-01
Abbott Point Of Care Inc. — i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is a…Class II · 2012-03-07
Abbott Point Of Care Inc. — i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are p…Class II · 2015-06-15
Abbott Point Of Care Inc. — i-STAT CG4+ cartridge (white). List Number: 03P85-25.Class II · 2025-08-21
Abbott Point Of Care Inc. — i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K8…Class II · 2025-08-21
Abbott Point Of Care Inc. — i-STAT EG7+ cartridge. List Number: 03P76-25.Class II · 2025-08-21
Abbott Point Of Care Inc. — i-STAT EG6+ cartridge. List Number: 03P77-25.Class II · 2025-08-21
Abbott Vascular — Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, Mit…Class II · 2022-09-08
Abbott Vascular — Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, Mit…Class II · 2022-09-08
Abbott Vascular — Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, Mit…Class II · 2022-09-08
Abbott Vascular — Brand Name: RX Accunet Embolic Protection System Common Name: RX Acc…Class II · 2011-11-30
Abbott Vascular — MitraClip Clip Delivery System, product number MSK0101. The MitraClip…Class I · 2016-02-04
Abbott Vascular — 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)Class II · 2022-03-11
Abbott Vascular — 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-…Class II · 2022-03-11
Abbott Vascular — 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)Class II · 2022-03-11
Abbott Vascular — INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)Class II · 2022-03-11
Abbott Vascular — Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-0…Class II · 2022-03-11
Abbott Vascular — PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended…Class II · 2018-07-03
Abbott Vascular — Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.…Class I · 2022-03-30
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK …Class I · 2020-01-29
Abbott Vascular — NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK…Class I · 2020-01-29
Abbott Vascular — NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC …Class I · 2020-01-29
Abbott Vascular — NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC …Class I · 2020-01-29
Abbott Vascular — NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC …Class I · 2020-01-29
Abbott Vascular — NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC …Class I · 2020-01-29
Abbott Vascular — NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC …Class I · 2020-01-29
Abbott Vascular — StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. …Class II · 2017-02-10
Abbott Vascular — Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part:…Class II · 2019-05-01
Abbott Vascular — NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448…Class I · 2017-03-22
Abbott Vascular — NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 10…Class I · 2017-03-22
Abbott Vascular — NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T…Class I · 2017-03-22
Abbott Vascular — Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The…Class I · 2017-04-26
Abbott Vascular — Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x…Class II · 2020-03-25
Abbott Vascular — Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dil…Class II · 2012-08-20
Abbott Vascular Inc — 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedu…Class II · 2024-11-06
Abbott Vascular Inc — 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use duri…Class II · 2024-11-06
Abbott Vascular Inc — 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for c…Class II · 2024-11-06
Abbott Vascular Inc — 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiova…Class II · 2024-11-06
Abbott Vascular, Inc. — HT Connect Peripheral Guide Wire Part Number Description 101258…Class II · 2013-11-25
Abbott's Compounding Pharmacy, Inc. — Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compoundi…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Ab…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, T…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compoun…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compoun…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx i…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, T…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, T…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, Thi…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, Thi…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigera…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refri…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refriger…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL uni…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL u…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL an…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL un…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL uni…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and …Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL uni…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL uni…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, un…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, ro…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compou…Class II · 2016-01-15
Abbott's Compounding Pharmacy, Inc. — papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, Th…Class II · 2016-01-15
AbbVie Inc — Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Ad…Class II · 2014-03-10
AbbVie Inc — Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Ad…Class II · 2014-03-10
AbbVie Inc — LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dos…Class II · 2014-03-10
AbbVie Inc — Lupron Depot (leuprolide acetate for depot suspension) Single Dose Ad…Class II · 2014-03-10
AbbVie Inc — Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Ad…Class II · 2014-03-10