Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 11, 2025 | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schill... | Class II | Merge Healthcare, Inc. |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 2023B, ... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 7, Soft... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 | Blood collection tubes were manufactured with the label applied too high on the tube, which shif... | Class II | Greiner Bio-One North America, Inc. |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 12A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 10B, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 6 Servi... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 9B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 11A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.9... | Vital sign monitoring instrument may trigger an error message during blood pressures measurement... | Class II | Schiller, Ag |
| Aug 8, 2025 | IntelliSpace Cardiovascular, Software 8.0.0.4. | Software issue that results in the display of outdated information. | Class II | Philips Medical Systems Nederland B.V. |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 8B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 11B, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valve... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-F... | Class II | Baxter Healthcare Corporation |
| Aug 7, 2025 | FloPatch FP120, REF: FP120-FOT01-005 | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-0... | Class III | Flosonics Medical (R/A 1929803 ONTARIO CORP.) |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, cla... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 0733294000... | As a result of Post-Market half-time stability testing, false negative test result was observed f... | Class II | Cepheid |
| Aug 6, 2025 | Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and ... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to d... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Aug 6, 2025 | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. ... | Potential for undetected, deformed a-traumatic tips. | Class I | Olympus Corporation of the Americas |
| Aug 6, 2025 | Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit con... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and f... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ... | Reports of out-of-box failures discovered during the limited launch phase. Failure modes included... | Class II | Maquet Cardiovascular, LLC |
| Aug 6, 2025 | Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer.... | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag ... | Class II | ICU Medical Inc. |
| Aug 6, 2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... | The catheters may not retain their shape. | Class I | Medtronic Perfusion Systems |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | Alcon Research LLC |
| Aug 5, 2025 | Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works... | Due to a software issue, there is a potential image error of the Region of Interest for expansion... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 5, 2025 | t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,... | A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and ve... | Class II | Tandem Diabetes Care, Inc. |
| Aug 5, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Uni... | Due to incomplete seals in the pouch which provide the sterile barrier. | Class II | 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.