Class IIOngoingZ-2882-2026
Happiest Baby, Inc recalls Happiest Baby
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Happiest Baby, IncCAAug 12, 2026
Recalls: Reprocessing Controls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
Class IIOngoingZ-1613-2026
Olympus Corporation Of The Americas recalls Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus Corporation of…PAApr 1, 2026
Class IIOngoingZ-1612-2026
Olympus Corporation Of The Americas recalls Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus Corporation of…PAApr 1, 2026
Class IIOngoingZ-1611-2026
Olympus Corporation Of The Americas recalls Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus Corporation of…PAApr 1, 2026
Class IIOngoingZ-1610-2026
Olympus Corporation Of The Americas recalls Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Olympus Corporation of…PAApr 1, 2026
Class IIOngoingZ-0574-2026
Sterilmed, Inc. recalls Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism…
Sterilmed, Inc.MNNov 26, 2025
Class IIOngoingZ-0573-2026
Sterilmed, Inc. recalls Brand Name: ACUSON
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism…
Sterilmed, Inc.MNNov 26, 2025
Class IIIOngoingZ-2265-2025
DRG International, Inc. recalls Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-456…
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 inste…
DRG International, Inc…NJAug 13, 2025
Class IIOngoingZ-0837-2025
Karl Storz Endoscopy recalls Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Karl Storz EndoscopyCAJan 22, 2025