Class IIOngoingZ-2673-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…

Zimmer Surgical IncDover, OH, United StatesReported Jul 8, 2026 · 10 days ago

Legal News Analyst · Jul 8, 2026

Reason for recall

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

Lot / code information

Lot #: Code:
Model: 60-1812-101-00 ; Case (20-pack)
UDI: (01)00889024381162(17)271125(10)78938271 ; Box (10-Pack)
UDI: (01)00889024378469(17)271125(10)78938271 ; Individual
UDI: (01)00889024367173(17)271125(10)78938271
Lot #: 78938271
Model: 60-1812-101-00 ; Case (20-pack)
UDI: (01)00889024381162(17)271126(10)78938272 ; Box (10-Pack)
UDI: (01)00889024378469(17)271126(10)78938272 ; Individual
UDI: (01)00889024367173(17)271126(10)78938272

What the firm is doing

On June 8, 2026, the firm began notifying consignees titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to locate and quarantine affected product in their inventory. Customers may either return the affected product, or a Zimmer Biomet sales representative may remove and return the affected product on the customer's behalf. If the product has been further distributed, the distributor should notify downstream customers and accounts of the recall. All customers should ensure that affected personnel are aware of the recall. This recall is related to prior recall RES 98665, conducted to remove Mixing Bowl and Spatula due to similar issues with seal integrity.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada and EMEA.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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