Browse Device Recalls
2,817 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,817 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 2,817 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2025 | Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. ... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. ... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW ve... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. ... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW v... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR s... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and... | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a... | Class II | Medtronic Neuromodulation |
| Dec 3, 2025 | BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1... | Due a software issue that may result in equipment not receiving timely updates of patient, medica... | Class II | CareFusion 303, Inc. |
| Dec 3, 2025 | Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW versio... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Philips Incisive CT | Potential for incomplete scan due to unstable connection inside of floating sensor. | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Dec 3, 2025 | SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| 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 | 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 | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | KWIK-STIK 6-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. |
| 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 |
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.