Stradis Healthcare recall records

19 reported ongoing

20 records in this archive. Latest source date Dec 15, 2022.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7....

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs...
FDA device enforcement

HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed...
FDA device enforcement

HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distrib...
FDA device enforcement

Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcar...
FDA device enforcement

McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Dis...
FDA device enforcement

Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactu...
FDA device enforcement

Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Official source for Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. ...

Reasons in these listed records

  • Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
  • Potential for incomplete seals.
  • There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

These examples come from this result page and are not a ranking of every recall reason.

Checking Stradis Healthcare

Is there a recall on stradis healthcare right now?

This archive contains 20 records, including 19 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking