Class IIOngoingZ-1488-2026
Olympus Corporation Of The Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. Th…
Potential for rubber fragment detachment during use.
Olympus Corporation of…PAMar 11, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 985–996 of 3,866 recalls
Class IIOngoingZ-1487-2026
Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Datascope Corp.NJMar 11, 2026
Class IIOngoingZ-1486-2026
Datascope Corp. recalls CS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Datascope Corp.NJMar 11, 2026
Class IIOngoingZ-1485-2026
Aesculap Inc recalls Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Cata…
There is the potential for the length of the trocar shaft to be too long.
Aesculap IncPAMar 11, 2026
Class IIOngoingZ-1484-2026
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Siemens Healthcare Dia…NYMar 11, 2026
Class IIOngoingZ-1483-2026
B Braun Medical Inc recalls Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802…
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
B Braun Medical IncPAMar 11, 2026
Class IIOngoingZ-1482-2026
B Braun Medical Inc recalls Brand Name: B. Braun Product Name: 21GA WINGED INFUSION
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
B Braun Medical IncPAMar 11, 2026
Class IIOngoingZ-1481-2026
B Braun Medical Inc recalls Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog…
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
B Braun Medical IncPAMar 11, 2026
Class IIOngoingZ-1480-2026
Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens (TICL)
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause:…
Staar Surgical AGMar 11, 2026
Class IIOngoingZ-1479-2026
Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy S…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1478-2026
Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotr…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1477-2026
Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithot…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Olympus Corporation of…PAMar 11, 2026