Browse Device Recalls

206 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 206 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 206 FDA device recalls in 2026.

Date	Product	Reason	Class	Firm
Jan 20, 2026	GEM Premier 5000; Part No. 00055430011.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No: 00055415011.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No. 00055430004.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No. 00055415010.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	Atellica CH Urine Albumin (UAlb). Material Number: 11537225	Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concen...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 20, 2026	cobas pro integrated solutions with cobas c 503 analytical units: cobas pr...	Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spl...	Class II	Roche Diagnostics Operations, Inc.
Jan 20, 2026	GEM Premier 5000; Part No. 00055445004.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000 PAK; Part No. 00055360008.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000 PAK; Part No. 00055407510.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No. 00055445008.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000 PAK; Part No. 00055407508.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000 PAK; Part No. 00055360011.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000 PAK; Part No. 00055407511.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No. 00055415008.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No. 00055430008.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Model No. 00055430010.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000; Part No. 00055415005.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 20, 2026	GEM Premier 5000 PAK, Part No. 00055360004.	Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ...	Class II	Instrumentation Laboratory
Jan 16, 2026	Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla...	Issue with software algorithm which may lead to overpressure events.	Class I	Olympus Corporation of the Americas
Jan 16, 2026	MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)...	Potential packaging failures, which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026	GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Number...	Under certain workflows, patient information shown in the viewer may not match the images display...	Class II	GE Healthcare
Jan 16, 2026	Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf...	Issue with software algorithm which may lead to overpressure events.	Class I	Olympus Corporation of the Americas
Jan 16, 2026	Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff...	Issue with software algorithm which may lead to overpressure events.	Class I	Olympus Corporation of the Americas
Jan 16, 2026	Private Label CVS. Model Number: CVS405406. Helps maintain a moist woun...	Potential packaging failures, which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026	MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 3180...	Potential packaging failures, which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jan 15, 2026	Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Mo...	Knee and Humeral socket implants contain incorrect labeling.	Class II	Encore Medical, LP
Jan 15, 2026	MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010	Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or ca...	Class II	KOB GmbH
Jan 15, 2026	Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM ...	There is the potential for the length of the trocar shaft to be too long.	Class II	Aesculap Inc
Jan 15, 2026	Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUM...	Knee and Humeral socket implants contain incorrect labeling.	Class II	Encore Medical, LP
Jan 15, 2026	Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCK...	Knee and Humeral socket implants contain incorrect labeling.	Class II	Encore Medical, LP
Jan 14, 2026	PIE Trolley System Model: 2005	Lack of 510K clearance	Class II	Edermy LLC
Jan 14, 2026	PIE PAK Models: P2HC-A, P2HC-S, P2HC	Lack of 510K clearance	Class II	Edermy LLC
Jan 13, 2026	Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3...	Pumps were released without full testing being performed, including occlusion alarm testing.	Class II	Baxter Healthcare Corporation
Jan 13, 2026	Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800...	units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable ...	Class II	Laerdal Medical Corporation
Jan 13, 2026	Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Produ...	During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was i...	Class II	Medtronic Perfusion Systems
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/16;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/12;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8521/11;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8521/09;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-2836/11;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-2835/12;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/15;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8521/15;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8030/12;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/11;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 9, 2026	Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;	Internal investigations have identified an issue with the durability of the connecting cable near...	Class II	Maquet Cardiopulmonary Gmbh
Jan 9, 2026	Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca...	Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.	Class II	Medartis AG

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.