Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging
Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation indicates potential for adverse health consequences. Two different surgical needle holder models were swapped during packaging and labeling, creating risk of wrong instrument use during medical procedures. No illnesses or injuries have been reported, placing this recall in the High category for risk-of-harm medical devices without reported harm.
Plain-English summary
Aesculap Inc. is recalling the MB215R MILLS DUROGRIP TC Micro Needle Holder (straight, 203mm), a surgical instrument used in medical procedures. Approximately 60 units were affected by this recall.
Between November 23, 2022 and October 6, 2023, two different needle holder models were inadvertently distributed with swapped product labels and packaging. The MB215R was shipped with MB362R labeling, while MB362R was shipped with MB215R labeling. The FDA notes this issue may lead to a short delay in surgical procedures.
The affected products were distributed nationwide to medical facilities in California, Colorado, Florida, Idaho, Kentucky, Maryland, Missouri, Montana, Nevada, New York, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, and Virginia.
Healthcare facilities should verify their inventory to ensure products match their packaging labels. If you have received affected units, contact Aesculap Inc. directly for a replacement.
The recalled product
- Product
- MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
- Manufacturer
- Aesculap Inc
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 2022 and October 6
- 2023.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Aesculap Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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