RegWardenFDA facility compliance records
Recall

Class II — Aesculap Inc

Recalling firmAESCULAP, INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonNeedle 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.
ProductMB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
Quantity53
DistributionUS Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
Initiated2023-12-29
Classified2024-01-31
Recall numberZ-0866-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Aesculap Inc (Z-0866-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93793/

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