Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns
Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of infection from non-sterile medical devices in a sterile operative field, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. The recall involves 174,960 units of the Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon, which were reprocessed by Sterilmed and sterilized with Ethylene Oxide (EO). The affected units are distributed nationwide in the United States and include all lot numbers with expiration dates of July 2016 or prior.
The recall is being conducted because Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of adverse events related to this issue.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact Sterilmed, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
- Manufacturer
- STERILMED, INC.
- Affected units
- 174,960
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · STERILMED, INC.
See all →- HighReprocessed imaging catheters recalled after exceeding validated reprocessing cycles
FDA (Devices) · 2025-11-26
- HighNon Siemens imaging catheters recalled after exceeding validated reprocessing cycles
FDA (Devices) · 2025-11-26
- HighSterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns
FDA (Devices) · 2018-10-17
- SevereSterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
FDA (Devices) · 2018-01-03
- ModerateSterilmed Recalls Reprocessed EP Ablation Cables Due to Regulatory Status
FDA (Devices) · 2017-07-12
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSterilmed Recalls Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling
FDA (Devices) · 2015-10-07
- HighZimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak
FDA (Devices) · 2020-03-04
- HighStryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling
FDA (Devices) · 2020-05-06
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08
- ModerateZimmer Surgical Recalls Tourniquet Cuffs with Missing Instructions
FDA (Devices) · 2015-08-12