Zimmer Surgical Recalls Sterile Tourniquet Hoses

Source: FDA · United States

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 14,360 units of Sterile Tourniquet Hoses for A.T.S. 4000 TS Tourniquet Systems due to potential sterility breach.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 7, 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 due to potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.

Which Products Are Affected

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 Product Quantity: 14,360 units Lot Numbers: 79701946, 79701947, 79701948, 80555938, 80555939, 80555940, 80581869, 80581870, 80765021 Distribution: US Nationwide, Canada, and EMEA Recall Number: Z-2674-2026

What You Should Do

If the issue is discovered prior to use, it may result in a clinically insignificant extension of surgery to find another device. Check lot codes against the listed UDI information.

Why This Matters

The Class II recall involves a potential sterility issue that could lead to moderate localized infection if the affected devices are used.

Source

FDA recall Z-2674-2026, initiated June 9, 2026.

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Zimmer Surgical Inc. is recalling 14,360 units of Sterile Tourniquet Hoses for A.T.S. 4000 TS Tourniquet Systems due to potential sterility breach.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.