Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Dec 2, 2025 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus An... | Affected implants may have undersized distal diameter along length of the shaft, which could lead... | Class II | Zimmer, Inc. |
| Nov 29, 2025 | BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Fem... | Labeling error, Incorrect expiration date | Class II | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
| Nov 28, 2025 | RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStatio... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 | Certain pumps have potentially been released from service with defective grease applied to the ca... | Class II | Baxter Healthcare Corporation |
| Nov 28, 2025 | RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. S... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 28, 2025 | Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Numbe... | Potential for the invalidation for calculated radiation dose does not work as intended for certai... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 27, 2025 | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr... | Behind-the-ear sound processer packaging label is different then included product. | Class II | Advanced Bionics, LLC |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007... | Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR m... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immun... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 25, 2025 | Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Ca... | Butyrate tube cracks during actuation, rendering product unusable. | Class II | Ferndale Laboratories, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impu... | Class I | Draeger, Inc. |
| Nov 24, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Alcon Research 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.