Z-0867-2024Class II

MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"

Name: Z-0867-2024 MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Creator: Aesculap Inc
Published: 2023-12-29
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2023-12-29 / Open, Classified / root cause: manufacturing process

FDA source

Aesculap Inc began a recall of MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM" on 2023-12-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0867-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-29
Posted: 2024-01-31
Recalling firm: Aesculap Inc
Product: MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Product code: HCF Instrument, Ligature Passing And Knot Tying
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 60
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 codes and lots: UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0867-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0867-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31

Product code HCF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)