Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 18, 2019
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
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,…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Navigation, Inc. recalled Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 - a moderate-severity action.
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 was recalled by Medtronic Navigation, Inc. in December 18, 2019. Reason: The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there ex…. Check the official notice for the remedy. Verify recall #Z-0657-2020 with the FDA Devices before acting.
The recall
Medtronic Navigation, Inc. issued this moderate-severity FDA Devices recall-The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there ex….
- Moderate
- severity level
- Class II
- classification
- December 18, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0657-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0657-2020) was formally reported on December 18, 2019, with the manufacturer initiating the action on October 30, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Navigation, Inc. is listed as the recalling firm, operating out of Louisville, CO. Federal records list the affected scope as 10,448 disposable biopsy needles.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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,Michig…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,448 disposable biopsy needles
Related Recalls
6
0 from same agency
Product description
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Reason for 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0657-2020 |
| Date reported | December 18, 2019 |
| Date initiated | October 30, 2019 |
| Recalling firm | Medtronic Navigation, Inc. |
| Firm location | Louisville, CO |
| Affected scope | 10,448 disposable biopsy needles |
| 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,Mississ… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0657-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943. Recalled by Medtronic Navigation, Inc.. Units affected: 10,448 disposable biopsy needles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0657-2020.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0657-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported December 18, 2019.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.