Brand Name: Sterile Tourniquet Hoses recallZ-2674-2026 · Zimmer Surgical Inc · initiated Jun 9, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Surgical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company 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.
Recall details
- Recall number
- Z-2674-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 9, 2026
- Posted by the FDA
- Jul 2, 2026
- Recalling firm
- Zimmer Surgical Inc
- Quantity
- 14360
- Product code
- KCY
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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 ; Lot Number 80555939 Model No. 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 Number 80555940 Model No. 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 Number 80581869 Model No. 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 Number 80581870 Model No. 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 Number 80765021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- A.T.S.® 60-4009-101-00Zimmer Orthopaedic Surgical Products, Inc. · Tourniquet, Pneumatic1 recall3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99186).
- Z-2673-2026 · Open, ClassifiedBrand 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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