Lower risk Medical device recall · FDA · Published December 13, 2021

FEMSelect EnPlace Pelvic Floor Repair System Recall: Missing Channel Tube Limiter

FEMSelect recalls specific lots of EnPlace pelvic floor repair system due to potential missing Channel Tube Limiter. This may affect surgical safety during use.

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

🇺🇸 FDA recall #Z-0556-2022Medical device FEMSelect ›

Lower-risk recall

Certain lots may not have been packaged wth the Channel Tube Limiter.

Take action

Contact the company

Recalling firmFEMSelect LtdHaMa'ayan 2, First Floor · Modi'in, Israel

✎ GovInfoNow plain-language explainer

FEMSelect is recalling two specific lots of their EnPlace single-use pelvic floor repair system because some units might not have the Channel Tube Limiter included. This could lead to improper surgical handling during procedures. Read more at govinfonow.com/recall/61434-femselect-enplace-pelvic-floor-repair-system-recall-missing-channel-tube.

Source Summary by GovInfoNow · govinfonow.com/recall/61434-femselect-enplace-pelvic-floor-repair-system-recall-missing-channel-tube · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0556-2022

Cite this page

“FEMSelect EnPlace Pelvic Floor Repair System Recall: Missing Channel Tube Limiter.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61434-femselect-enplace-pelvic-floor-repair-system-recall-missing-channel-tube. Based on FDA recall #Z-0556-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0556-2022%22&limit=1).

FEMSelect Ltd recalled The EnPlace single-use trans-vaginal pelvic floor repair system due to packaging defects, the FDA said on Dec. 13, 2021. The recall involves 141 units distributed nationwide and in Georgia.

How to tell if you have it

Brand: FEMSelect
Product: The EnPlace
Lot Numbers: 21072510 and 21072512

The hazard

Certain lots may not have been packaged with the Channel Tube Limiter. The device enables delivery of a tissue anchor to the ligaments of the vaginal cavity.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Pelvic Lap Pack Kits: Catheter Issues Recalled (2026-05-04) and Medline Medical Procedure Kits Recall: Catheter Issues (2026-05-04).

How to tell if you have this one

Check the lot numbers on the packaging: 21072510 or 21072512. The EnPlace system is a single-use trans-vaginal pelvic floor repair device sold for surgical use.

Brand
FEMSelect
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 21072510 or 21072512 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of Georgia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 58 days after the firm started it.

Dec 13, 2021Firm started the recall
Feb 2, 2022FDA classified it Class II
Feb 9, 2022Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

More FEMSelect recalls

Link to this recall

<a href="https://govinfonow.com/recall/61434-femselect-enplace-pelvic-floor-repair-system-recall-missing-channel-tube">FEMSelect EnPlace Pelvic Floor Repair System Recall: Missing Channel Tube Limiter (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-0556-2022 (December 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0556-2022 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.