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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 14,360
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.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer Surgical Inc
See all →- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08
- ModerateA.T.S. 3200TS tourniquets recalled over screens that may freeze
FDA (Devices) · 2026-02-04
- ModerateTourniquet systems recalled over screens that may freeze in non-English settings
FDA (Devices) · 2026-02-04
- ModerateAir dermatomes recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24
- ModerateDermatome AN units recalled because the thickness control bar may be misaligned
FDA (Devices) · 2025-12-24
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- ModerateZimmer Surgical Recalls A.T.S. 4000TS Tourniquet Systems for Labeling Updates
FDA (Devices) · 2018-02-21
- HighZimmer Recalls ATS 3000 Tourniquets Due to Counterfeit Chip Failures
FDA (Devices) · 2012-11-21
- HighZimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak
FDA (Devices) · 2020-03-04
- HighSterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns
FDA (Devices) · 2015-12-16
- ModerateTourniquet systems recalled over screens that may freeze in non-English settings
FDA (Devices) · 2026-02-04
- HighMedline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk
FDA (Devices) · 2025-01-01