Lower risk Medical device recall · FDA · Published October 30, 2019

Medtronic Biopsy Needle Kit Recall: Depth Stop May Not Securely Tighten

Medtronic recalls biopsy needle kits with potential depth stop issues that could delay surgery. Affected units include specific product numbers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0658-2020Medical device Medtronic ›

Lower-risk recall

The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.

Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710

✎ GovInfoNow plain-language explainer

Medtronic is recalling biopsy needle kits that may not securely tighten, potentially delaying surgery. This issue affects specific product numbers and lot numbers sold to medical professionals. Read more at govinfonow.com/recall/66584-medtronic-biopsy-needle-kit-recall-depth-stop-may-not-securely.

Source Summary by GovInfoNow · govinfonow.com/recall/66584-medtronic-biopsy-needle-kit-recall-depth-stop-may-not-securely · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0658-2020

Cite this page

“Medtronic Biopsy Needle Kit Recall: Depth Stop May Not Securely Tighten.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66584-medtronic-biopsy-needle-kit-recall-depth-stop-may-not-securely. Based on FDA recall #Z-0658-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2020%22&limit=1).

The FDA announced on 2019-10-30 that Medtronic Navigation, Inc. is recalling the Biopsy Needle FPU Kit due to a manufacturing issue where depth stops may not tighten securely, potentially delaying surgery. This voluntary Class II recall affects units distributed across the United States.

How to tell if you have it

Brand: Medtronic
Product: Biopsy Needle FPU Kit
Product #: 9731754
UDI: 00643169341517
Lot Numbers: 0009665221, 0009709452, 0009960538

The hazard

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since 2017-06-07. Recent Medtronic recalls include issues with PIN surgical pins not fitting patient reference frames (2024-12-04), software anomalies causing flipped images in StealthStation S8 App versions 1.3.0 and 1.3.2 (2024-08-22), and missing digits during neurosurgery with Stealth S8 Software (2024-03-26). Other recent recalls of similar products include Medline Medical Kits Recall regarding syringe disconnection risk (2026-02-27) and Medline Medical Procedure Kits Recall concerning catheter issues (2026-05-04).

How to tell if you have this one

Check for product number 9731754 and lot numbers 0009665221, 0009709452, or 0009960538 on the kit packaging.

Brand
Medtronic
Category
Medical device

FDA recall event · 3 products

All 3 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
Ongoing
Distribution
US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jersey,New Mexico,New York,North Carolina,North Dakota,Ohio,Oklahoma,Oregon,Pennsylvania,South Carolina,South Dakota,Tennessee,Texas,Utah,Vermont,Virginia,Washington,West Virginia,Wisconsin,Wyoming, OUS: None: Australia, Austria,Bangladesh,Belgium,Bosnia And Herzegovina,Brazil,Bulgaria,Canada,Canary Islands,China,Colombia,Costa Rica,Croatia,Czech Republic,Denmark,Ecuador,Egypt,Finland,France,Germany,Greece,Hungary,Iceland,India,Indonesia,Ireland,Israel,Italy,Japan,Jordan,Kazakhstan,Kenya,Korea, Republic Of,Latvia,Lebanon,Luxembourg,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Pakistan,Philippines,Poland,Portugal,Puerto Rico,Qatar,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Slovakia,Slovenia,South Africa,Spain,Sweden,Switzerland,Thailand,Turkey,United Arab Emirates,United Kingdom

Recall number	Product, codes & lots	Quantity
Z-0657-2020	Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943; Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518	10,448 disposable biopsy needles
Z-0658-2020	Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517; Lot Numbers: 0009665221 0009709452 0009960538	12 disposable biopsy needles
Z-0659-2020	Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108; Lot Numbers: 0009754921 0009921274 0009940846 0009921273 0009921276 0009952564	1 disposable Biopsy Needle

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product number and lot numbers on the kit packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 49 days after the firm started it.

Oct 30, 2019Firm started the recall
Dec 6, 2019FDA classified it Class II
Dec 18, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

Check the product number and lot numbers on the packaging to see if it is affected; no specific action is required beyond verification.

Is there a risk of serious injury?

The recall states a potential delay in surgery, but no mention of serious injury or death. The hazard level is low risk.

Similar recalls

Latest medical device recalls

Keep exploring

More Medtronic recalls

Link to this recall

<a href="https://govinfonow.com/recall/66584-medtronic-biopsy-needle-kit-recall-depth-stop-may-not-securely">Medtronic Biopsy Needle Kit Recall: Depth Stop May Not Securely Tighten (GovInfoNow)</a>

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-0658-2020 (October 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0658-2020 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.