Surgical needle holders distributed with incorrect product labels
Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries and the hazard presented is administrative (procedural delay), not a direct patient safety threat. Labeling errors without reported harm are classified as Moderate per the rubric.
Plain-English summary
Aesculap Inc is recalling the MB362R JACOBSON DUROGRIP TC Micro Needle Holder due to a distribution labeling error. Fifty-three units were shipped with incorrect product labels: some MB215R needle holders were labeled as MB362R, while some MB362R needle holders were labeled as MB215R.
This mix-up may result in a delay in surgical procedures when healthcare personnel select the wrong needle holder model based on the incorrect label.
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. Products were distributed between November 23, 2022, and October 13, 2023.
If your facility received this product during the affected distribution period, verify that the actual product model matches the label before using it in procedures. Contact Aesculap Inc with any questions or to report issues.
The recalled product
- Product
- MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
- Manufacturer
- Aesculap Inc
- Hazard
- labeling-error
- product-mix-up
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 13
- 2023.
Distribution
Distributed nationwide across the United States.
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