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 |
|---|---|---|---|---|
| Dec 30, 2021 | Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... | Class II | Howmedica Osteonics Corp. |
| Dec 30, 2021 | RayStation/RayPlan- designed for treatment planning and analysis of radiation... | If a new primary image set is selected while the cine loop is running, the primary image set will... | Class II | RAYSEARCH LABORATORIES AB |
| Dec 30, 2021 | Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... | Class II | Howmedica Osteonics Corp. |
| Dec 29, 2021 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pro... | There is the potential for reduced or non-delivery of medication, in some cases without alerting ... | Class I | Baxter Healthcare Corporation |
| Dec 29, 2021 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Inside the packaging of one reported item a non-conforming product was found. Contrary to the des... | Class II | Stryker Leibinger GmbH & Co. KG |
| Dec 29, 2021 | YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR ... | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Ind... | Class II | Young Dental Mfg Co I LLC |
| Dec 29, 2021 | Baxter Spectrum IQ Infusion Pumps, Product code 3570009. | There is the potential for reduced or non-delivery of medication, in some cases without alerting ... | Class I | Baxter Healthcare Corporation |
| Dec 29, 2021 | MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes | Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 29, 2021 | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. | The proximal opening of the inserts exhibit an out of specification condition which would prevent... | Class II | XTANT Medical |
| Dec 28, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | The affected lot was placed under quarantine in September 2021 due to complaints of alleged false... | Class I | CELLTRION USA INC |
| Dec 28, 2021 | Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial samplin... | The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. ... | Class II | Hobbs Medical, Inc. |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Mo... | Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | Class II | Hill-Rom, Inc. |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Contou... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with E... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vec... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthon... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Discov... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infini... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T S... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 | Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, addi... | Class II | Intuitive Surgical, Inc. |
| Dec 23, 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valv... | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) | Class II | Olympus Corporation of the Americas |
| Dec 23, 2021 | Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Mode... | Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | Class II | Hill-Rom, Inc. |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSp... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 23, 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA ... | The magnetic resonance systems could potentially have a cryogen ventilation system that does not ... | Class II | GE Healthcare, LLC |
| Dec 22, 2021 | HYDRATOME RX 44-30MM/260CM Material Number: M00583050 | Sterility of device is compromised due to a sterile barrier breach | Class II | Boston Scientific Corporation |
| Dec 22, 2021 | JAGTOME RX 49-30-260-035 Material Number: M00573020 | Sterility of device is compromised due to a sterile barrier breach | Class II | Boston Scientific Corporation |
| Dec 22, 2021 | JAGTOME RX 49-30-450-035 Material Number: M00573030 | Sterility of device is compromised due to a sterile barrier breach | Class II | Boston Scientific 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.