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U.S. Department of Health and Human Services

Medical Device Recalls

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RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1... 1 05/22/2026 FEI # 1000135961
Bolton Medical Inc.
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 ... 2 05/22/2026 FEI # 3014421917
O&M HALYARD INC
Automated Impella Controller (AIC); Product Code: 0042-0000-US; 1 05/22/2026 FEI # 1220648
Abiomed, Inc.
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 3342... 2 05/21/2026 FEI # 1018233
C.R. Bard Inc
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-N... 2 05/21/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10... 2 05/21/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (7220... 2 05/21/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below pro... 2 05/21/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary... 2 05/20/2026 FEI # 1000116158
Medtronic Perfusion Systems
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary... 2 05/20/2026 FEI # 1000116158
Medtronic Perfusion Systems

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