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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 Software Version: N/A Product Description:...

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.

Zimmer SurgicalHealth & Personal CareMedical DevicesLot Code: Model No. 60-1812-101-00Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 9, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 9, 2026
Hazard Level
HIGH
Brand
Zimmer Surgical
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Zimmer Surgical
Model numbers
Lot Code: Model No. 60-1812-101-00, Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271, Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271, Individual UDI (01)00889024367173(17)271125(10)78938271, Lot Number 78938271 Model No. 60-1812-101-00, Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272, Box (10-Pack) UDI (01)00889024378469(17)271126(10)78938272, Individual UDI (01)00889024367173(17)271126(10)78938272 +12 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 9, 2026

  2. Reported by FDA DEVICE

    July 8, 2026

  3. RecallRadar source check

    July 14, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zimmer Surgical Inc or your healthcare provider for instructions. Notification method: Letter

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Full Description

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 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A. Reason: 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.. Classification: Class II. Quantity: 45160. Distribution: Worldwide distribution - US Nationwide and the countries of Canada and EMEA.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot Code: Model No. 60-1812-101-00
Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271
Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271
Individual UDI (01)00889024367173(17)271125(10)78938271
Lot Number 78938271 Model No. 60-1812-101-00
+15 more
Affected States
ALL
Report Date
July 8, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Zimmer Tourniquet Systems Recalled Due to Screen Malfunction

Zimmer Surgical Inc recalled 206 A.T.S. 5000TS Tourniquet Systems on December 24, 2025. The device can freeze or become unresponsive in certain non-English language settings. This issue may delay patient care during emergencies.

Zimmer Surgical
Device user
Read more