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AESCULAP MB215RRecalls & reported problems

Aesculap, Inc. · MILLS DUROGRIP TC Micro Needle Holder, straight, 8", (203 mm), with 0.2 mm pitch of serration, round handle, with ratchet, suture 6/0 - 10/0, non-sterile, reusable · 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

  1. Dec 29, 2023Open, Classified

    Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.

    Z-0867-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Other INSTRUMENT, LIGATURE PASSING AND KNOT TYING devices

All INSTRUMENT, LIGATURE PASSING AND KNOT TYING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.