M.D.L. Soft Tissue Biopsy Needles Recall: Sterility Risk
M.D.L. recalls specific soft tissue biopsy needles due to potential sterility compromise. Affected models and lot numbers listed. Consumers should check their items and contact the manufacturer for details.
Lower-risk recall
Sterility assurance may be compromised.
Contact the company
What happened, in plain English
M.D.L. is recalling certain soft tissue biopsy needles because they might not be sterile. This could lead to infections if used improperly. Affected items include specific models and lot numbers listed in the recall. Read more at govinfonow.com/recall/62056-m-d-l-soft-tissue-biopsy-needles-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62056-m-d-l-soft-tissue-biopsy-needles-recall-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2492-2021
Cite this page
“M.D.L. Soft Tissue Biopsy Needles Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62056-m-d-l-soft-tissue-biopsy-needles-recall-sterility-risk. Based on FDA recall #Z-2492-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2492-2021%22&limit=1).
Why it’s dangerous
The needles may not be sterile, which could cause infections if used during medical procedures. This risk is specific to the recalled models and lot numbers.
Who’s affected
Medical professionals and patients who use these needles for biopsies may be affected. Those with the listed models and lot numbers are most at risk.
How to tell if you have this one
Check the model number and lot number on the needle packaging. Affected models include MGK11210, MGK11410, and others listed with specific lot numbers.
- Brand
M.D.L.- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2489-2021 | Bone Marrow Transplantation biopsy needle; Model PI1535/100, Lot Numbers: 3620D Model PIL1410/75, Lot Numbers: 1617A Model PIL1435/100, Lot Numbers: 1617A Model PIL1510/75, Lot Numbers: 3620D, 3620E Model PIL1535/100, Lot Numbers: 5216C, 3620D Model PIL1610/75, Lot Numbers: 3620D, 3620E, 4120 Model PIL1635/100, Lot Numbers: 5216C Model PIL1835/100, Lot Numbers: 5216C Model PIP1410/50, Lot Numbers: 1617A Model PIP1430/70, Lot Numbers: 1617A Model PIP1510/50, Lot Numbers: 1217B, 1618A Model PIP1530/70, Lot Numbers: 1617A Model PIP1630/70, Lot Numbers: 1617A Model PIP1810/50, Lot Numbers: 0818, 1618A Model PIP1830/70, Lot Numbers: 1617A Model PJ0810, Lot Numbers: 3620D Model PJ1110, Lot Numbers: 3620D, 4920B Model PJ1306, Lot Numbers: 3620D Model PJE1110, Lot Numbers: 5216, 5216C, 1417A, 3517C, 4617, 0818, 1418, 2518A, 4018, 4318D, 5018, 1119B, 1119C, 1119A, 3620D Model PJK21110, Lot Numbers: 3616C, 3620D Model PJK21115, Lot Numbers: 3416C Model PJK21310, Lot Numbers: 3416C, 3620D Model PJT0810, Lot Numbers: 4220B, 4320D, 4320D Model PJT0815, Lot Numbers: 4220D, 4320E Model PJT1110, Lot Numbers: 1417A, 3620D, 3620D, 3620D, 4220B, 4220B, 4220B, 4220A, 4320F, 4320D Model PJT1115, Lot Numbers: 3620D, 4220B, 4320D Model PJT1306, Lot Numbers: 1417A, 3517C, 3620D, 3620E, 4220B, 4320D Model PJT1310, Lot Numbers: 3620D, 4220B, 4420A, 4320D Model PS0810, Lot Numbers: 2518A, 1119A Model PS1110, Lot Numbers: 4316, 4316A, 4316B, 4316B, 2618, 4018, 3620D Model PS1115, Lot Numbers: 3620D Model PS1306, Lot Numbers: 3620D Model PS1310, Lot Numbers: 3916, 3620D | 21,518 units |
| Z-2490-2021 | Aspirated Cyto-Histological Biopsy needle; Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A | 2750 devices |
| Z-2491-2021 | Mammary Nodules Localization; Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D | 320 units |
| Z-2492-2021 | Soft Tissue Biopsy Needles; 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 | 20,129 units |
| Z-2493-2021 | General Manual surgical instrument; Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A | 4120 units |
What to do — step by step
Check Needle Details
Look for the model number and lot number on the needle packaging to see if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these needles safe to use?
The recall states sterility may be compromised, so they should not be used until the manufacturer confirms they are safe.
How do I know if my needles are affected?
Check the model number and lot number against the list provided in the recall notice.
What should I do if I have the affected needles?
Contact M.D.L. directly to confirm if your needles are affected and follow their instructions.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2492-2021 (August 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2492-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.