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Soft Tissue Biopsy Needles

FDA Device Recall #Z-2492-2021 — Class II — August 5, 2021

Recall Summary

Recall Number Z-2492-2021
Classification Class II — Moderate risk
Date Initiated August 5, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm M.D.L. S.r.l.
Location Delebio
Product Type Devices
Quantity 20,129 units

Product Description

Soft Tissue Biopsy Needles

Reason for Recall

Sterility assurance may be compromised.

Distribution Pattern

Nationwide

Lot / Code Information

Model MGK11210, Lot Numbers: 5216C Model MGK11410, Lot Numbers: 5216C, 1217B, 3620D Model MGK11413, Lot Numbers: 5216C Model MGK11415, Lot Numbers: 3620D Model MGK11610, Lot Numbers: 5216C, 3620D Model MGK11615, Lot Numbers: 3620D Model MGK11616, Lot Numbers: 5216C, 1217B Model MGK11620, Lot Numbers: 1617A Model MGK11810, Lot Numbers: 5216C Model MGK11816, Lot Numbers: 5216C Model MGK11820, Lot Numbers: 5216C, 1217B, 4617 Model MGK11825, Lot Numbers: 5216C, 1217B, 3620D, 3620E Model PD01415, Lot Numbers: 3620D, 3620E Model PD01416, Lot Numbers: 5216C, 1417A Model PD01420, Lot Numbers: 5216C Model PD01610, Lot Numbers: 5216C, 0817A, 0818, 1618A, 1918A, 3620D, 3620E Model PD01615, Lot Numbers: 3620D, 3620E Model PD01616, Lot Numbers: 5216C, 1417A Model PD01620, Lot Numbers: 5216C Model PD01810, Lot Numbers: 5216C, 0817A, 0817A, 1617A, 0818, 1618A, 1918A Model PD01816, Lot Numbers: 5216C, 0817A, 0817A, 1617A Model PD01820, Lot Numbers: 5216C, 2217A, 2217A Model PD02007, Lot Numbers: 1617A, 2217A, 0119 Model PD02010, Lot Numbers: 5216C, 0817A, 2217A, 1918A Model PD02016, Lot Numbers: 5216C, 0817A, 2217A Model PD02020, Lot Numbers: 5216C, 0817A Model PD0PP1407, Lot Numbers: 0718 Model PD0PP1410, Lot Numbers: 5216C, 3620D, 3620E Model PD0PP1415, Lot Numbers: 3620D, 3620E Model PD0PP1416, Lot Numbers: 5216C Model PD0PP1420, Lot Numbers: 5216C Model PD0PP1610, Lot Numbers: 5216C, 4018, 1119A, 3620D, 3620E Model PD0PP1615, Lot Numbers: 3620D, 3620E, 4220C Model PD0PP1616, Lot Numbers: 5216C, 1119A Model PD0PP1620, Lot Numbers: 5216C Model PD0PP1807, Lot Numbers: 4018, 0219 Model PD0PP1810, Lot Numbers: 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1815, Lot Numbers: 1417C Model PD0PP1816, Lot Numbers: 5216C, 1217B, 1417A, 2217A, 5018, 0219, 1119A Model PD0PP1820, Lot Numbers: 5216C, 1417A, 2217A, 2618B, 0219, 1119A Model PD0PP1825, Lot Numbers: 5216C, 1417A Model PD0PP2007, Lot Numbers: 1617A, 0119, 0219 Model PD0PP2010, Lot Numbers: 0417, 1417A, 2217A, 0918, 0219 Model PD0PP2016, Lot Numbers: 1417A, 2217A, 0818A, 0818B, 1218A, 0219, 1119A Model PD0PP2020, Lot Numbers: 1417A, 2217A, 0219, 1119A Model TY1410, Lot Numbers: 5216C, 1417A, 1817, 1618A, 3620D Model TY1412, Lot Numbers: 1617A Model TY1416, Lot Numbers: 5216C, 1417A Model TY1420, Lot Numbers: 1417A Model TY1610, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1612, Lot Numbers: 1618A Model TY1616, Lot Numbers: 5216C, 0817 Model TY1620, Lot Numbers: 5216C Model TY1810, Lot Numbers: 5216C, 0818, 1618A, 1918A, 3620D Model TY1812, Lot Numbers: 2217, 1618A Model TY1816, Lot Numbers: 5216C Model TY1820, Lot Numbers: 5216C, 1417A, 1417C, 0818, 1618A, 1918A Model TY1825, Lot Numbers: 5216C, 2217A, 1618A, 3620D Model TY1830, Lot Numbers: 1618A Model TY2010, Lot Numbers: 5216C Model TY2016, Lot Numbers: 5216C Model TY2020, Lot Numbers: 5216C, 1417A Model TYC1410, Lot Numbers: 5216C, 1417A Model TYC1412, Lot Numbers: 1617A Model TYC1416, Lot Numbers: 5216C Model TYC1810, Lot Numbers: 5216C, 2217A Model TYC1812, Lot Numbers: 2217 Model TYC1816, Lot Numbers: 5216C, 2217A Model TYC1820, Lot Numbers: 1417A, 2117A Model TYC2010, Lot Numbers: 5216C, 2217A Model TYC2016, Lot Numbers: 5216C, 2217A Model TYC2020, Lot Numbers: 1417A, 2117A, 2217A

Other Recalls from M.D.L. S.r.l.

Recall # Classification Product Date
Z-2491-2021 Class II Mammary Nodules Localization Aug 5, 2021
Z-2493-2021 Class II General Manual surgical instrument Aug 5, 2021
Z-2490-2021 Class II Aspirated Cyto-Histological Biopsy needle Aug 5, 2021
Z-2489-2021 Class II Bone Marrow Transplantation biopsy needle Aug 5, 2021

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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