Class IIOngoingZ-3120-2026
HeartSine Technologies Ltd recalls HeartSine SAM 350P 350P US Device
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
HeartSine Technologies…Sep 16, 2026
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 348 recalls
Class IIOngoingZ-3017-2026
Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Medical Care
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
Fresenius Medical Care…MASep 2, 2026
Class IIOngoingZ-3016-2026
Henry Schein Inc. recalls Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Henry Schein Inc.PASep 2, 2026
Class IIOngoingZ-3015-2026
Henry Schein Inc. recalls Structur 2 SC Temporary Resin Cartridge Refill 75Gm
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Henry Schein Inc.PASep 2, 2026
Class IIOngoingZ-3014-2026
Canon Medical System, USA, INC. recalls Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiogr…
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Canon Medical System,…CASep 2, 2026
Class IIOngoingZ-2998-2026
Hollister Ulc recalls Onli 17cm Hydrophilic Urethral Intermittent Catheter
Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.
Hollister UlcSep 2, 2026
Class IIOngoingZ-2964-2026
AVID Medical, Inc. recalls Halyard LAVH PACK
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
AVID Medical, Inc.VAAug 26, 2026
Class IIOngoingZ-2953-2026
Intersurgical Inc recalls One-Piece Guedel Airway
Devices could potentially be occluded or partially occluded.
Intersurgical IncNYAug 26, 2026
Class IIOngoingZ-2952-2026
Intersurgical Inc recalls One-Piece Guedel Airway
Devices could potentially be occluded or partially occluded.
Intersurgical IncNYAug 26, 2026
Class IIOngoingZ-2941-2026
BD SWITZERLAND SARL recalls 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus…
Products may not have received adequate sterilization processing.
BD SWITZERLAND SARLAug 19, 2026
Class IIOngoingZ-2933-2026
OBP Medical Corporation recalls OBP Medical
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
OBP Medical Corporatio…MAAug 19, 2026
Class IIOngoingZ-2915-2026
W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
W L Gore & Associates,…AZAug 19, 2026