CLASS II ONGOING Device recall · Reported 27 Oct 2021 · FDA Enforcement Report

IUD Insertion Pack recalled by Stradis Medical

Stradis Medical is recalling IUD Insertion Pack, distributed nationwide in the US. The recall was initiated on 10 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 618-034

Quantity recalled20 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0127-2022
FDA event ID: 88656
Recalling firm: Stradis Medical, Peachtree Corners, GA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Sep 2021
FDA classified: 16 Oct 2021
Reported: 27 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Sep 2021	Recall initiated by company
16 Oct 2021	Classified by FDA	+36 days
27 Oct 2021	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Product as listed by the FDA

IUD Insertion Pack

Where it was distributed

Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

Nationwide Alaska Arizona California Colorado Florida Georgia Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Missouri Montana North Carolina New Jersey Nevada New York

Questions about this recall

Is IUD Insertion Pack recalled?

Yes. Stradis Medical recalled IUD Insertion Pack on 10 Sep 2021. The recall is Class II and its status is Ongoing. Recall number Z-0127-2022.

Why was it recalled?

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Which lots are affected?

Part Number: 618-034

Where was it sold?

Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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