Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
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 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
Lot / code information
- Lot #
- Code:
- Model
- 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 #
- 79701946
- Model
- 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 #
- 79701947
- Model
- 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 #
- 79701948
- Model
- 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 #
- 80555938
- Model
- 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
- Lot #
- 80555939
- Model
- 60-4009-101-00 ; Case (20-pack)
- UDI
- (01)00889024382336(17)280326(10)80555940 ; Box (10-Pack)
- UDI
- (01)00889024380455(17)280326(10)80555940 ; Individual
- UDI
- (01)00889024376786(17)280326(10)80555940
- Lot #
- 80555940
- Model
- 60-4009-101-00 ; Case (20-pack)
- UDI
- (01)00889024382336(17)280911(10)80581869 ; Box (10-Pack)
- UDI
- (01)00889024380455(17)280911(10)80581869 ; Individual
- UDI
- (01)00889024376786(17)280911(10)80581869
- Lot #
- 80581869
- Model
- 60-4009-101-00 ; Case (20-pack)
- UDI
- (01)00889024382336(17)280331(10)80581870 ; Box (10-Pack)
- UDI
- (01)00889024380455(17)280331(10)80581870 ; Individual
- UDI
- (01)00889024376786(17)280331(10)80581870
- Lot #
- 80581870
- Model
- 60-4009-101-00 ; Case (20-pack)
- UDI
- (01)00889024382336(17)280402(10)80765021 ; Box (10-Pack)
- UDI
- (01)00889024380455(17)280402(10)80765021 ; Individual
- UDI
- (01)00889024376786(17)280402(10)80765021
- Lot #
- 80765021
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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 detailsHide
Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2674-2026
- FDA device classification · KCYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.5910The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Zimmer Surgical IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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