Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowle... Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the br... Class II Oakworks Inc
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis ... Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... Class II Exactech, Inc.
Jun 29, 2021 Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip pro... Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was mar... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 29, 2021 Exactech Connexion GXL acetabular polyethylene liners used in the following s... Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients w... Class II Exactech, Inc.
Jun 28, 2021 MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 There is an incorrect version of the needle in the introducer part of devices. The affected Lots ... Class II MY01, INC.
Jun 28, 2021 AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part ... Complaints have been received concerning the humeral stem failing to mate with the broach handles... Class II Encore Medical, LP
Jun 25, 2021 KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodonti... Product label intended for the European community was distributed to the USA market via their US ... Class II Straumann USA LLC
Jun 25, 2021 CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 Product labeled as Cutting Electrode may contain BIVAP electrode. Class II Richard Wolf GmbH
Jun 25, 2021 The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS... Potential patient exposure to the graphite substrate. Class II Tornier S.A.S.
Jun 25, 2021 OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 The firm identified a precipitation issue which may cause late Ct reactors (a false positive resu... Class II OPTI Medical Systems, Inc
Jun 25, 2021 Infusomat Space Volumetric Pump Administration Set, Product Code 490100 There is a potential for the Anti-free flow clip of the administration set to be inverted which m... Class II B. Braun Medical, Inc.
Jun 24, 2021 AMX Navigate Mobile X-Ray System An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray ... Class II GE Healthcare, LLC
Jun 24, 2021 ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeru... Class II Biomerieux Inc
Jun 24, 2021 cobas infinity central lab running software version 3.01.03 through 3.02.08, ... Under specific circumstances created by the user, the cobas e flow test results could be replaced... Class II Roche Diagnostics Operations, Inc.
Jun 24, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-1... There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the wate... Class II CardioQuip, LLC
Jun 23, 2021 Covidien Sonicision Reusable Generator-converts electrical power from the bat... Potential for a manufacturing assembly error-may result in a non-functional audio indicator of de... Class II Covidien Llc
Jun 23, 2021 TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79... Due to complaints received regarding incomplete/open packaging seals potentially causing product ... Class II Bard Peripheral Vascular Inc
Jun 23, 2021 Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10... Software anomalies that may lead to the generation of erroneous results. Class II Beckman Coulter, Inc.
Jun 23, 2021 EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen C... Due to complaints received regarding incomplete/open packaging seals potentially causing product ... Class II Bard Peripheral Vascular Inc
Jun 23, 2021 TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acqu... Due to complaints received regarding incomplete/open packaging seals potentially causing product ... Class II Bard Peripheral Vascular Inc
Jun 22, 2021 MYLA software. Used to manage microbiology test workflow from the reception ... Software anomaly - Under certain conditions, unwanted alterations to results could be applied whe... Class II BioMerieux SA
Jun 21, 2021 muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... Class II Murata Vios, Inc.
Jun 21, 2021 DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) ... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c)... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 383257... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA

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.