Aesculap Inc: Micro Needle Holders Recalled for Incorrect Distribution and Labeling

What You Should Do

1. Identify if you have the affected surgical instruments by checking the model numbers and UDI-DI codes on the packaging or device: JACOBSON DUROGRIP (MB362R) with UDI-DI 4046955075546 or MILLS DUROGRIP (MB215R) with UDI-DI 4046955075379.
2. Check the distribution dates: affected JACOBSON models (MB362R) were distributed between November 23, 2022, and October 13, 2023; affected MILLS models (MB215R) were distributed between November 23, 2022, and October 6, 2023.
3. Verify that the physical instrument matches the model number on its label to ensure model MB215R was not mislabeled as MB362R or vice versa.
4. Contact Aesculap Inc. or your healthcare facility's equipment manager to report any misidentified instruments and to receive instructions for returns or replacements.
5. Contact your healthcare provider or the manufacturer at their Pennsylvania headquarters for further instructions and potential refund or replacement options.
6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products