Class IIOngoingZ-1492-2026
Vascutek, Ltd. recalls Gelsoft Plus
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.…
Vascutek, Ltd.Mar 11, 2026
Recalls: Error in labeling
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–22 of 22 recalls
Class IIOngoingZ-1203-2026
Cardinal Health 200, LLC recalls Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Card…
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older.…
Cardinal Health 200, L…ILFeb 4, 2026
Class IICompletedZ-1130-2026
LEASEIR TECHNOLOGIES SLU recalls Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b…
The console label for affected devices is missing the "DANGER" symbol.
LEASEIR TECHNOLOGIES S…Jan 28, 2026
Class IIIOngoingZ-0226-2026
Home Health US, Incorporated recalls One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854…
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Home Health US, Incorp…FLOct 29, 2025
Class IIOngoingZ-2479-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS98407…
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical interv…
MEDLINE INDUSTRIES, LP…ILSep 3, 2025
Class IIOngoingZ-2463-2025
Zhejiang Luyao Electronics Technology Co., Ltd. recalls Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number:…
Regulatory documentation error and misleading color packaging claim.
Zhejiang Luyao Electro…Sep 3, 2025
Class IIOngoingZ-2453-2025
BD SWITZERLAND SARL recalls BD PhaSeal Injector Luer (N30C)
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
BD SWITZERLAND SARLSep 3, 2025
Class IIIOngoingZ-2324-2025
Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date.…
Diversatek HealthcareCOAug 20, 2025
Class IIIOngoingZ-1815-2025
Beckman Coulter Ireland, Inc. recalls Apo B Reagent
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total…
Beckman Coulter Irelan…Jun 4, 2025
Class IIOngoingZ-1141-2025
HF Acquisition Co LLC recalls Biological
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer'…
HF Acquisition Co LLCWAFeb 19, 2025