Zimmer Surgical Recalls Sterile Tourniquet Hoses
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Zimmer Surgical Inc. is recalling 45,160 units of A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to potential sterility breach.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Zimmer Surgical Inc. initiated a voluntary recall of Sterile Tourniquet Hoses after identifying a potential sterility breach in the sealing area of the sterile pouch. The recall is classified as Class II by the FDA. If used, the issue may result in moderate localized infection.
Which Products Are Affected
The affected product is 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. A total of 45,160 units are affected. Distribution is worldwide, including US Nationwide, Canada, and EMEA countries. Multiple lot numbers are involved, including 78938271, 78938272, 78938273, 80555986, 80555987, 80555988, 80555989, 80555990, 80568849, 82010858, 82010859, 82196691, 82196692, 82331021, 82331022, 82418900, 82418901, 82639501, 82761025, 83343102, 84859541, 84859542, and 86156905, with corresponding UDIs listed in the recall.
What You Should Do
Consumers and facilities should follow instructions provided in the firm's notification letter. If the issue is discovered prior to use, obtain an alternative device.
Why This Matters
The potential sterility breach could lead to moderate localized infection if the product is used.
Source
FDA recall number Z-2673-2026, report date 20260708.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,322 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.