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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.