Medtronic Navigation, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0657-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

Product Classification:

Class II

Date Initiated: October 30, 2019

Date Posted: December 18, 2019

Recall Number: Z-0657-2020

Event ID: 84191

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.

Status: Ongoing

Product Quantity: 10,448 disposable biopsy needles

Code Information:

Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated