Browse Device Recalls

34,608 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,608 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 34,608 FDA device recalls — Class II.

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DateProductReasonClassFirm
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 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 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 Diowave Laser System, REF: Diowave 250W Software update is needed for laser systems, for topical infrared heating to provide temporary re... Class II Technological Medical Advancements LLC
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
Jan 9, 2026 FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 5... It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X... Class II FUJIFILM Healthcare Americas Corporation
Jan 9, 2026 Brand Name: APTUS Product Name: 2.5 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
Jan 8, 2026 Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product ... Mis-wired component-the improperly wired component can result in additional noise on the power su... Class II Olympus Corporation of the Americas
Jan 8, 2026 Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS ... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHA... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Me... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG S... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 8, 2026 Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBS... Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issu... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; If the connection between a mint Lesion workstation and the mint Lesion server is interrupted whi... Class II Mint Medical GmbH
Jan 7, 2026 Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Num... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT ... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 See complete list in RES, exceeds character limit. Medline Surgical Gowns Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A Medline has identified issues related to calibration of the equipment used to sterilize and packa... 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.