Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,093–1,104 of 2,908 recalls
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode.…
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Surgical drape packs may have open seals, which may compromise the sterility of the product.
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially lea…
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure…
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.