Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code N... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code N... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, R... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM ... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM ... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM ... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Siz... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pla... | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... | Class II | Biomet, Inc. |
| Jan 7, 2022 | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pi... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, ... | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 7, 2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E | Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antisep... | Class II | Baxter Healthcare Corporation |
| Jan 6, 2022 | Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number ... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 6, 2022 | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 6, 2022 | Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 98971... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 6, 2022 | FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 6, 2022 | BD Vacutainer Luer Lok Access Device - intended as a sterile, single use devi... | May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cel... | Class III | Becton Dickinson & Company |
| Jan 6, 2022 | Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 5, 2022 | BD Veritor Plus Analyzer - intended to provide rapid test results in near-pat... | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized ... | Class II | Becton Dickinson & Co. |
| Jan 5, 2022 | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in t... | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to... | Class II | DePuy Orthopaedics, Inc. |
| Jan 5, 2022 | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component ... | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to... | Class II | DePuy Orthopaedics, Inc. |
| Jan 4, 2022 | INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw | Class II | Smith & Nephew, Inc. |
| Jan 4, 2022 | The Optima Coil System consists of an implantable embolization coil comprised... | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch la... | Class II | BALT USA, LLC |
| Jan 3, 2022 | CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Det... | The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospina... | Class II | Immuno-Mycologics, Inc |
| Jan 3, 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version ... | eCareManager (eCM) Sentry Score software not approved for use | Class II | Philips North America 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.