Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 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 1,023 FDA device recalls — Class III.

Clear

Date	Product	Reason	Class	Firm
Jul 1, 2019	Erisma- LP posterior fixation system with the below specifically affected pro...	Potential for the polyaxial screw to become disassembled during implant.	Class III	Clariance Inc
Jun 27, 2019	EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 P...	EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.	Class III	Baxter Healthcare Corporation
Jun 24, 2019	TAPSYSTEM Model 2A, REF 8002A	There is a potential for an assembly error resulting in the battery wire being connected to the O...	Class III	Cardiocommand Inc.
Jun 10, 2019	Assayed Bovine Multi-Sera Level 1, Model No. AL1027	The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generat...	Class III	Randox Laboratories, Limited
Jun 7, 2019	Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re...	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a...	Class III	Polymer Technology Systems, Inc.
Jun 7, 2019	PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ...	The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a...	Class III	Polymer Technology Systems, Inc.
Jun 4, 2019	inLight Medical LED Pads used with Polychromatic light technology system	LED pads with cord connectors that have v-shaped notches may not have been assembled properly. Th...	Class III	Inlightened Partners LLC
May 24, 2019	ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for...	Presence of a time dependent, stability drift in patient and control results returned from ARCHIT...	Class III	Abbott Laboratories
May 24, 2019	ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar...	Presence of a time dependent, stability drift in patient and control results returned from ARCHIT...	Class III	Abbott Laboratories
May 16, 2019	Cepheid Xpert C. difficile/Epi Control Panel	Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.	Class III	Microbiologics Inc
May 10, 2019	Replacement ECG leadwires with snap ends REF/Catalog Number Description 210...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Mode...	Possible corrosion of the battery contact(s).	Class III	Cardiocommand Inc.
May 10, 2019	ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cab...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 EC...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
May 10, 2019	Replacement leadwires with grabber ends: REF/Catalog Number Description 210...	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr...	Class III	GE Healthcare, LLC
Apr 29, 2019	Philips Patient Information Center iX configured with a regional setting whic...	Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ...	Class III	Philips North America, LLC
Apr 29, 2019	Philips IntelliBridge System configured with a regional setting which uses a ...	Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ...	Class III	Philips North America, LLC
Apr 26, 2019	Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D...	There is an error in the chromomap on the package insert.	Class III	Cytocell Ltd.
Apr 9, 2019	ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHIT...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 9, 2019	ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR...	Devices were delivered without the required dry ice.	Class III	Abbott Laboratories
Apr 4, 2019	SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085...	The manufacturer received complaints that customers were attempting to install the fitting softwa...	Class III	Advanced Bionics, LLC
Apr 4, 2019	cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s...	There is a potential for the tray input flap on the post analytical units to become loose, potent...	Class III	Roche Diagnostics Corporation
Apr 4, 2019	cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s...	There is a potential for the tray input flap on the post analytical units to become loose, potent...	Class III	Roche Diagnostics Corporation
Apr 3, 2019	2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1...	Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.	Class III	Fresenius Medical Care Renal Therapies Group, LLC
Mar 20, 2019	Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Produ...	Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes	Class III	GETINGE US SALES LLC
Mar 19, 2019	BIOPHEN LMWH Control C4, REF 224201	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t...	Class III	Aniara Diagnostica LLC
Mar 19, 2019	BIOPHEN UFH Control C1, REF 224101	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t...	Class III	Aniara Diagnostica LLC
Mar 19, 2019	BIOPHEN UFH Control C2, REF 223901	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t...	Class III	Aniara Diagnostica LLC
Mar 18, 2019	HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode RE...	Three materials used in the makeup of the implant were mistakenly left off the list of bio-compat...	Class III	Advanced Bionics, LLC
Mar 15, 2019	Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific re...	There is an error in the chromomap included in the labeling for the product.	Class III	Cytocell Ltd.
Mar 4, 2019	Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Produ...	The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.	Class III	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Feb 27, 2019	Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF...	The device label incorrectly states that the device is sterile. This product is an externally app...	Class III	Teleflex Medical
Feb 27, 2019	Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF ...	The device label incorrectly states that the device is sterile. This product is an externally app...	Class III	Teleflex Medical
Feb 27, 2019	McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numb...	Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA...	Class III	Cypress Medical Products LLC
Feb 25, 2019	Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog...	Updates to the Instructions for Use.	Class III	Cook Medical Incorporated
Feb 25, 2019	Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Appro...	Updates to the Instructions for Use.	Class III	Cook Medical Incorporated
Feb 25, 2019	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog...	Updates to the Instructions for Use.	Class III	Cook Medical Incorporated
Feb 25, 2019	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number...	Updates to the Instructions for Use.	Class III	Cook Medical Incorporated
Feb 25, 2019	NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides...	The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard ...	Class III	Nidek, Inc.
Feb 25, 2019	Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Ca...	Updates to the Instructions for Use.	Class III	Cook Medical Incorporated
Feb 25, 2019	Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number...	Updates to the Instructions for Use.	Class III	Cook Medical Incorporated
Feb 22, 2019	Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ...	The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduc...	Class III	GE Healthcare, LLC

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.