Labeling errors medical devices recalls
6 FDA Class I medical devices recall events since Jan 1, 2025 whose stated reason matches “Labeling errors”. Grouping is by keyword in FDA's reason text — see methodology.
Recalls
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Bolton Medical Inc. medical device recall: RelayPro Thoracic Stent-Graft System
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
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Omnicell, Inc. medical device recall: Rolls of label stock used with the Omnicell i.v.Station. 1. Part…
Potential for mislabeled syringe produced by the i.v.STATION device.
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Trividia Health, Inc. medical device recall: Owner's Booklets and Instructions for Use that are used with the…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and…
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Medline Industries, LP medical device recall: Sterile Medline Convenience Kits: 1) MAJOR PACK L-F
Convenience kits labeled as sterile have not gone through the sterilization process.
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B Braun Medical Inc medical device recall: Microbore Extension Set with 0.2 Micron Filter. Catalog Number:…
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated…
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Calyxo, Inc. medical device recall: CVAC Aspiration System
Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with…