The Recall Desk
ModerateFDA (Devices)·Z-2674-2026·Announced 2026-07-08

Sterile Tourniquet Hoses recalled for potential sterility breach

Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a medical device with a potential sterility issue. The source text explicitly states the issue may result in "moderate localized infection" if used, but no illnesses or injuries are reported. The hazard is conditional on use and would be detected before surgery in many cases. Class II recalls with potential for moderate harm but no reported adverse events typically fall at severity score 2.

Plain-English summary

Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors (Model 60-4009-101-00) worldwide, including distribution in the US, Canada, and EMEA countries. The recall involves approximately 14,360 units affected by a potential sterility breach in the sealing area of the sterile pouch.

If the affected hose is used in surgery, the sterility issue may result in moderate localized infection. If the breach is discovered prior to use, the only consequence may be a clinically insignificant extension of surgery to locate and use another readily available device.

Healthcare providers and hospitals should check their inventory for the recalled lot numbers and affected UDIs listed in the FDA recall notice. Do not use units from the affected lots. Contact Zimmer Surgical Inc or the FDA with any questions or to report adverse events.

The recalled product

Product
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical Equipment
Hazard
  • sterility-breach
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Code: Model No. 60-4009-101-00
  • Case (20-pack) UDI (01)00889024382336(17)271022(10)79701946
  • Box (10-Pack) UDI (01)00889024380455(17)271022(10)79701946
  • Individual UDI (01)00889024376786(17)271022(10)79701946
  • Lot Number 79701946 Model No. 60-4009-101-00
  • Case (20-pack) UDI (01)00889024382336(17)271028(10)79701947
  • Box (10-Pack) UDI (01)00889024380455(17)271028(10)79701947
  • Individual UDI (01)00889024376786(17)271028(10)79701947
  • Lot Number 79701947 Model No. 60-4009-101-00
  • Case (20-pack) UDI (01)00889024382336(17)271030(10)79701948
  • Box (10-Pack) UDI (01)00889024380455(17)271030(10)79701948
  • Individual UDI (01)00889024376786(17)271030(10)79701948
  • Lot Number 79701948 Model No. 60-4009-101-00
  • Case (20-pack) UDI (01)00889024382336(17)280325(10)80555938
  • Box (10-Pack) UDI (01)00889024380455(17)280325(10)80555938
  • Individual UDI (01)00889024376786(17)280325(10)80555938
  • Lot Number 80555938 Model No. 60-4009-101-00
  • Case (20-pack) UDI (01)00889024382336(17)280402(10)80555939
  • Box (10-Pack) UDI (01)00889024380455(17)280402(10)80555939
  • Individual UDI (01)00889024376786(17)280402(10)80555939

Distribution

Distributed nationwide across the United States.

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