Browse Device Recalls

2,601 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,601 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 2,601 FDA device recalls in 2023.

Date	Product	Reason	Class	Firm
Dec 8, 2023	Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode...	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec...	Class I	Megadyne Medical Products, Inc.
Dec 8, 2023	Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode...	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec...	Class I	Megadyne Medical Products, Inc.
Dec 8, 2023	Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Elec...	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has rec...	Class I	Megadyne Medical Products, Inc.
Dec 8, 2023	WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Deskto...	Following an FDA-issued Warning Letter, the firm requested return of their research EEG system co...	Class II	WAVi Co.
Dec 8, 2023	Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table...	Loss of connectivity between the FlexArm and the Table due to a software issue.	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 8, 2023	XScribe CP Cardiac Stress Testing System, version 6, with below product names...	Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F...	Class II	Baxter Healthcare Corporation
Dec 8, 2023	Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope ...	Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result ...	Class II	Olympus Corporation of the Americas
Dec 7, 2023	ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100	A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP...	Class I	Globus Medical, Inc.
Dec 7, 2023	Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num...	During internal review of Polaris battery assembly data from the HiPot operation, a test systems ...	Class II	Medtronic Inc.
Dec 7, 2023	Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco...	Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distrib...	Class II	TERRAGENE S.A.
Dec 7, 2023	Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray Syste...	If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily ope...	Class II	Philips North America
Dec 7, 2023	Terragene Bionova PCD (PCD222-C)	Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distrib...	Class II	TERRAGENE S.A.
Dec 7, 2023	MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Numb...	The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static ...	Class II	Cook Medical Llc
Dec 6, 2023	Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC12...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Accure Laser System, Model: PFMS00004	Laser system's spot tracking system may become misaligned resulting in the possible risk of deliv...	Class II	Accure Acne, Inc
Dec 6, 2023	Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5m...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) P...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, ...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Impella Connect, software portal for online device management that allows cli...	The following features have been disabled from the web-based portal because the FDA has not evalu...	Class II	Abiomed, Inc.
Dec 6, 2023	Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Baxter Preveleak Surgical Sealant, Product Codes: ADS201808	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: ...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 9340...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG04...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the fo...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm	The microcatheter IFU contains an intended use that has not been evaluated by the FDA.	Class II	Stryker, Inc.
Dec 6, 2023	Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 m...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100,...	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ...	Class II	Baxter Healthcare Corporation
Dec 6, 2023	Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm	The microcatheter IFU contains an intended use that has not been evaluated by the FDA.	Class II	Stryker, Inc.
Dec 5, 2023	Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultras...	Backrest platform stress fracture - the table is not operational in an inclined position	Class II	Oakworks Inc
Dec 5, 2023	Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Ec...	Backrest platform stress fracture - the table is not operational in an inclined position	Class II	Oakworks Inc
Dec 5, 2023	Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Ec...	Backrest platform stress fracture - the table is not operational in an inclined position	Class II	Oakworks Inc
Dec 5, 2023	Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2	Instructions for Use have been updated to add the following warning: Use only M4 screws with the ...	Class II	Ambu Inc.
Dec 5, 2023	Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echoca...	Backrest platform stress fracture - the table is not operational in an inclined position	Class II	Oakworks Inc
Dec 4, 2023	Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th...	Class II	Shirakawa Olympus Co., Ltd.
Dec 4, 2023	Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC	The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu...	Class II	Olympus Corporation of the Americas
Dec 4, 2023	Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DR...	Convenience kits were manufactured and distributed with components which were subsequently recall...	Class I	Cardinal Health 200, LLC
Dec 4, 2023	SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS	Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch se...	Class II	Olympus Corporation of the Americas
Dec 4, 2023	Model No. CYF-5, Cystonephrofiberscope	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th...	Class II	Shirakawa Olympus Co., Ltd.
Dec 4, 2023	Model No. BF-P190, EVIS EXERA III Bronchovideoscope	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th...	Class II	Shirakawa Olympus Co., Ltd.
Dec 4, 2023	Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE,...	Convenience kits were manufactured and distributed with components which were subsequently recall...	Class I	Cardinal Health 200, LLC
Dec 4, 2023	Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0...	Convenience kits were manufactured and distributed with components which were subsequently recall...	Class I	Cardinal Health 200, LLC
Dec 4, 2023	Model No. CYF-5R, Cystonephrofiberscope	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th...	Class II	Shirakawa Olympus Co., Ltd.
Dec 4, 2023	Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC,...	Convenience kits were manufactured and distributed with components which were subsequently recall...	Class I	Cardinal Health 200, LLC
Dec 4, 2023	Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRA...	Convenience kits were manufactured and distributed with components which were subsequently recall...	Class I	Cardinal Health 200, LLC
Dec 4, 2023	Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th...	Class II	Shirakawa Olympus Co., Ltd.
Dec 4, 2023	Model No. BF-XP190, EVIS EXERA III Bronchovideoscope	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from th...	Class II	Shirakawa Olympus Co., Ltd.
Dec 4, 2023	Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, ...	Convenience kits were manufactured and distributed with components which were subsequently recall...	Class I	Cardinal Health 200, 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.