Medline Industries, Inc. GSP158AARecalls & reported problems
Medline Industries, Inc. · AMC MAJOR BASIN · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Nov 17, 2022Open, Classified
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Z-1078-2023 · Root cause: Device Design · FDA record ↗
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- Synergetics 18060Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ68217AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ80200BMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ39461JMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.