Browse Device Recalls
905 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 905 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 905 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 7, 2026 | Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CD... | 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) LVAD DRIVELINE TRAY, Model Number: DM1035; 2)... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJ... | 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) CVC PACK, Model Number: CVI4500A; 2) TOTE KAM... | 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, Model Number: DYNJ35363A; 2) SICK... | 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) BURN PACK, Model Number: DYNJ15668R; 2) BURN ... | 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) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; ... | 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) OB KIT, Model Number: DYKM2326; 2) KIT LABOR ... | 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) CENTRAL LINE UNIVERSAL INSERTI, Model Number: C... | 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) PICC CATHETER INSERTION TRAY, Model Number: CVI... | 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 UROLOGY SLING, Model Number: DYKMBNDL106; ... | 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) C-SECTION PACK, Model Number: CDS820080N; 2) ... | 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) ADMIT KIT, Model Number: DYKA1343A | 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) NEURO SHUNT- CODMAN, Model Number: CDS860018G; ... | 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 OPHTHALMIC RUPTURE GLOBE, Model Number: DYK... | 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) DRAWER 6-IV FLUIDS GL... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP24... | 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) ANGIO PROCEDURE PACK, Model Number:00-401824AA;... | 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) ARTHROSCOPY CDS, Model Number: CDS984609B; 2)... | 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) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE14... | 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) PICC LINE TRAY, Model Number:00-401993O; 2) C... | 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) HYSTEROSCOPY, Model Number: CDS984086I; 2) KI... | 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) MAJOR LAPAROTOMY CDS,... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model ... | 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 STC TRACHEOSTOMY, Model Number:DYKMBNDL55; ... | 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) ANGIO PROCEDURE PACK, Model Number:00-401824AB;... | 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 SURG ONC EXCISION BREAST, Model Number:DYKM... | 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.