Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Device

Covidien LLC: Compromised sterility due to breach of barrier

Agency Publication Date: May 31, 2016
Share:
Sign in to monitor this recall

Affected Products

Product: Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

All lots beginning with 110000037462 through Lot 120002259962

Lot Numbers:
120002259962
Product: Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034

All lots beginning with 110000142862 through lot 130002191062X

Lot Numbers:
130002191062X
Product: Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

All lots beginning with 110000233562 through lot 120002651262X

Lot Numbers:
120002651262X
Product: Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031

All lots beginning with 110000311162 through lot 15J101262X

Lot Numbers:
15J101262X
Product: Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037

All lots beginning with 110000311262 through lot 15G162262X

Lot Numbers:
15G162262X
Product: Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022

All lots beginning with 110000463762 through lot 15K235262

Lot Numbers:
15K235262
Product: Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056

All lots beginning with 110001358162 through lot 15C033262X

Lot Numbers:
15C033262X
Product: Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522

All lots beginning with 110000161662 through lot 15G255462X

Lot Numbers:
15G255462X
Product: Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

All lots beginning with 110000476162 through lot 15J070162X

Lot Numbers:
15J070162X
Product: Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545

All lots beginning with 110001420362 through lot 15C151862X

Lot Numbers:
15C151862X
Product: Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556

All lots beginning with 100000055262 through lot 15B223462X

Lot Numbers:
15B223462X
Product: Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319

All lots beginning with 100000010062 through lot 15J162962X

Lot Numbers:
15J162962X
Product: Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

All lots beginning with 100000009962 through lot 15J163262X

Lot Numbers:
15J163262X

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73427
Status: Resolved
Manufacturer: Covidien LLC
Manufactured In: United States
Units Affected: 13 products (713600; 114720; 2418560; 208348; 28085; 996002; 36040; 3152197; 350550; 70960; 87680; 372480; 199488)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.