MB362R - JACOBSON DUROGRIP TC Micro Needle Holder… recallZ-0866-2024 · Aesculap Inc · initiated Dec 29, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Aesculap Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On December 29, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL NOTIFICATION letters. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.

Recall details

Recall number: Z-0866-2024
Status: Open, Classified
Initiated by the company: Dec 29, 2023
Posted by the FDA: Jan 31, 2024
Recalling firm: Aesculap Inc
Quantity: 53
Product code: HCF
Distribution: US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.

Product description

MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

Code information (models, lots, serial numbers)

UDI-DI 4046955075546 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 13, 2023.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

AESCULAP MB362R
Aesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 93793).

Z-0867-2024 · Open, Classified
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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