Class IIOngoingZ-3259-2026
New York Embroidery Studio, Inc. recalls New York Embroidery Studio Trinity Non-Surgical Isolation Gown
Gowns do not consistently meet the minimum liquid-barrier performance required.
New York Embroidery St…NYSep 30, 2026
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 348 recalls
Class IIOngoingZ-3248-2026
CooperVision, Inc. recalls Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catal…
A small number of lenses within the affected lot are of the incorrect power.
CooperVision, Inc.NYSep 30, 2026
Class IIOngoingZ-3224-2026
Maquet SAS recalls PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Mode…
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Maquet SASSep 30, 2026
Class IIOngoingZ-3223-2026
Ventec Life Systems, Inc. recalls REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post…
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Ventec Life Systems, I…WASep 30, 2026
Class IIOngoingZ-3222-2026
Ventec Life Systems, Inc. recalls REF:HF2PC9 HomeFill Oxygen System
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Ventec Life Systems, I…WASep 30, 2026
Class IIOngoingZ-3221-2026
Ventec Life Systems, Inc. recalls HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Ventec Life Systems, I…WASep 30, 2026
Class IIOngoingZ-3216-2026
Olympus Corporation Of The Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Olympus Corporation of…PASep 30, 2026
Class IOngoingZ-3214-2026
Boston Scientific Corporation recalls Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
Boston Scientific Corp…MNSep 30, 2026
Class IIOngoingZ-3213-2026
PI CARDIA LTD recalls Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Transfemoral catheter, positing arm may detached due to weld issue.
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Process control
PI CARDIA LTDSep 23, 2026
Class IIOngoingZ-3212-2026
ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-…
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or a…
ICU Medical, Inc.ILSep 23, 2026
Class IIOngoingZ-3172-2026
WELL LEAD MEDICAL CO. LTD recalls SunMed Tracheal Tube
The 6Fr suction catheter could not pass through the samples smoothly.
WELL LEAD MEDICAL CO.…Sep 23, 2026
Class IIOngoingZ-3164-2026
Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/C…
Due to a software issue
Nuclein LLCTXSep 23, 2026