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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88656

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 10, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stradis Medical, LLC dba Stradis Healthcare

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Tenaculum, Plastic

Z-0126-2022
Recall number
Z-0126-2022
Initiated
September 10, 2021
Classification
Class II
Status
Ongoing
Quantity
2483 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: 356T

Distribution pattern

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.

device · product 2 of 6

IUD Insertion Pack

Z-0127-2022
Recall number
Z-0127-2022
Initiated
September 10, 2021
Classification
Class II
Status
Ongoing
Quantity
20 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: 618-034

Distribution pattern

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.

device · product 3 of 6

IUD Insertion Kit

Z-0128-2022
Recall number
Z-0128-2022
Initiated
September 10, 2021
Classification
Class II
Status
Ongoing
Quantity
14959 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: 935K

Distribution pattern

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.

device · product 4 of 6

Endometrial Biopsy Kit

Z-0129-2022
Recall number
Z-0129-2022
Initiated
September 10, 2021
Classification
Class II
Status
Ongoing
Quantity
1639 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: 936K

Distribution pattern

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.

device · product 5 of 6

Foundation Kit

Z-0130-2022
Recall number
Z-0130-2022
Initiated
September 10, 2021
Classification
Class II
Status
Ongoing
Quantity
790 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: A10

Distribution pattern

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.

device · product 6 of 6

Standard IUD Insertion Kit

Z-0131-2022
Recall number
Z-0131-2022
Initiated
September 10, 2021
Classification
Class II
Status
Ongoing
Quantity
280 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Part Number: M20

Distribution pattern

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.