Soft Tissue Biopsy Needles
Medical device recall Z-2492-2021. Published in FDA’s Enforcement Report on Sep 29, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 29, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 20,129 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Sterility assurance may be compromised.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Soft Tissue Biopsy Needles
20,129 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 3,244 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 5, 2021.
- FDA classified it on Sep 20, 2021.
- FDA’s Enforcement Report published it on Sep 29, 2021.
- FDA terminated it on May 4, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- M.D.L. S.r.l., of Delebio, Italy.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,244 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.