Vehicle Safety Product Safety Food Safety Pet Safety Drug Safety Device Safety Workplace Safety Bridge Safety Aviation Safety Dam Safety Nursing Homes Water Safety Railroad Safety Pipeline Safety Environmental

Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,602 FDA device recalls in 2020.

Clear
DateProductReasonClassFirm
Dec 10, 2020 SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor ... Device requires the use of an Isolation Transformer in combination with the SDM in home care sett... Class II SenTec AG
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General N... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, ... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. Class II Remel Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for genera... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for genera... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) ... GE Healthcare has become aware of a potential safety issue associated with the improper installat... Class II GE Healthcare, LLC
Dec 10, 2020 Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Dis... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 N... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 10, 2020 GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for ge... GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the ... Class II GE Healthcare, LLC
Dec 9, 2020 BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for adminis... BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ... Class II Becton Dickinson & Company
Dec 9, 2020 BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administ... BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to ... Class II Becton Dickinson & Company
Dec 9, 2020 Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 9... Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile st... Class II Riverpoint Medical, LLC
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization ... System table may tilt because the bolts that fasten the vertical column and the table top tilting... Class II Canon Medical System, USA, INC.
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization T... System table may tilt because the bolts that fasten the vertical column and the table top tilting... Class II Canon Medical System, USA, INC.
Dec 8, 2020 Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization T... System table may tilt because the bolts that fasten the vertical column and the table top tilting... Class II Canon Medical System, USA, INC.
Dec 8, 2020 Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas ... Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ... Class II Roche Diagnostics Operations, Inc.
Dec 8, 2020 BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e... Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro ... Class II Roche Diagnostics Operations, Inc.
Dec 8, 2020 BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identificatio... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identificatio... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identificatio... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product... A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without be... Class II The Magstim Company Limited
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 smiths medical portex Loss of Resistance Device, REF 100/398/000 The labeling was missing information on sterilization and prohibition of reuse. Class II Smiths Medical ASD Inc.
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system After the user selects the Lock-in command, the kV and mA values are not locked immediately and c... Class II PHILIPS HOME HEALTHCARE SOLUTION
Dec 8, 2020 BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification ... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identificatio... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 8, 2020 BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (... BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aur... Class II Becton Dickinson & Co.
Dec 7, 2020 Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel f... During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Class II Oto Med Inc
Dec 7, 2020 Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel... During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Class II Oto Med Inc
Dec 7, 2020 IOLMaster 700 When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient ... Class II Carl Zeiss Meditec AG
Dec 7, 2020 Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel fi... During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. Class II Oto Med Inc
Dec 5, 2020 visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitativ... Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the pr... Class II VISBY MEDICAL INC
Dec 2, 2020 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Produ... Due to the incorrect filter assembly. Class II ICU Medical, Inc.
Dec 2, 2020 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam ... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per cas... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)0761236705392... Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date sh... Class II Medela AG Medical Technology
Dec 2, 2020 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation
Dec 2, 2020 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea... Class II Steris Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.