Lower risk Medical device recall · FDA · Published February 25, 2022

Stradis Healthcare Surgical Kit Recall: Outer Bag May Be Perforated

Stradis Healthcare recalls Coryell Memorial Hosp Total, Joint Pack Surgical Kits with possible outer bag perforations that could breach sterility. Affected units include specific lot numbers and SKUs.

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

🇺🇸 FDA recall #Z-0866-2022Medical device Stradis Healthcare ›

Lower-risk recall

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Take action

Contact the company

Recalling firmStradis Medical, LLC dba Stradis Healthcare3025 Northwoods Pkwy · Peachtree Corners, GA 30071-1524

✎ GovInfoNow plain-language explainer

Stradis Healthcare is recalling Coryell Memorial Hosp Total, Joint Pack surgical kits because the outer bag might be torn or punctured, risking contamination of the sterile instruments. This could lead to infections during surgery if the kit is used without proper sterility. Read more at govinfonow.com/recall/61023-stradis-healthcare-surgical-kit-recall-outer-bag-may-be-perforated.

Source Summary by GovInfoNow · govinfonow.com/recall/61023-stradis-healthcare-surgical-kit-recall-outer-bag-may-be-perforated · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0866-2022

Cite this page

“Stradis Healthcare Surgical Kit Recall: Outer Bag May Be Perforated.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61023-stradis-healthcare-surgical-kit-recall-outer-bag-may-be-perforated. Based on FDA recall #Z-0866-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0866-2022%22&limit=1).

Stradis Healthcare recalled Coryell Memorial Hosp Total, Joint Pack - Surgical Kits due to sterility breach risks from perforated outer bags, according to the FDA on Feb. 25, 2022. Owners should contact the company for a refund.

How to tell if you have it

Brand: Stradis Healthcare
Product: Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
SKU/Part Number: 690-260
Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822

The hazard

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Context

GovInfoNow's records show Stradis Medical, LLC dba Stradis Healthcare has four other recalls on record since Sept. 10, 2021. Other recent recalls of similar products include AVID Medical Halyard Transport Bag Kit Recall (Jan. 2, 2026), Boston Scientific EndoVive Safety PEG Kit Recall (Feb. 10, 2026), and Medline Recalls Knee Surgery Kits Due to Sterility Risk (June 10, 2026).

How to tell if you have this one

Check the product for a perforated or torn outer bag. Affected kits have specific lot numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822.

Brand
Stradis Healthcare
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of IN, TX, and PA.

Recall number	Product, codes & lots	Quantity
Z-0862-2022	Surgicare Neuro Pack - Neurological Kit; SKU/Part Number 570-2224; UDI H65257022240 Lot Numbers: 20143461101, 20156461682, 20217462972, 20309467143, 20343467142, 20364467508, 20364468264, 21076471300, 21082471463, 21102472013, 21117472929, 21126473545	176 units
Z-0863-2022	Lum Lam Custom Pack - Anesthesia Kit; SKU/Part Number 570-2674; UDI H65257026741 Lot Numbers: 21300478831 and 21314479685	21 units
Z-0864-2022	Total Knee Pack - Surgical Kit; SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064	76 units
Z-0865-2022	Anterior Hip Pack - Surgical Kit; SKU/Part Number 570-2677; UDI H65257026770 Lot Numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21167474498, 21349479943	100 units
Z-0866-2022	Coryell Memorial Hosp Total, Joint Pack - Surgical Kit; SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822	348 units

Based on the official FDA remedy

What to do — step by step

Check Bag Integrity
Inspect the outer bag for tears or punctures that could compromise sterility.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution in the states of IN, TX, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Indiana, Pennsylvania, Texas.

Recall timeline

FDA published this recall 47 days after the firm started it.

Feb 25, 2022Firm started the recall
Apr 4, 2022FDA classified it Class II
Apr 13, 2022Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall is for potential sterility breaches, but the risk is low if the bag is intact. The hazard is not severe enough to cause serious injury in normal use.

What should I do if I find a torn bag?

Discard the kit immediately and contact Stradis Healthcare for replacement instructions.

Similar recalls

Latest medical device recalls

Keep exploring

More Stradis Healthcare recalls

Link to this recall

<a href="https://govinfonow.com/recall/61023-stradis-healthcare-surgical-kit-recall-outer-bag-may-be-perforated">Stradis Healthcare Surgical Kit Recall: Outer Bag May Be Perforated (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-0866-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0866-2022 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.