Class II U.S. Food and Drug Administration

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS recall: Device user interface (screen) may freeze or become unresponsive to touch

Recall published 9 months ago

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1201-2026
Published
February 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Zimmer Surgical Inc
Product type
Medical devices
Units affected
206
Made in
United States
Lot / code info
Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003" ; Lot No. 66722609 ; Serial No. 50066722609003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609004" ; Lot No. 66722609 ; Serial No. 50066722609004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609005" ; Lot No. 66722609 ; Serial No. 50066722609005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610001" ; Lot No. 66722610 ; Serial No. 50066722610001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610002" ; Lot No. 66722610 ; Serial No. 50066722610002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610003" ; Lot No. 66722610 ; Serial No. 50066722610003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610004" ; Lot No. 66722610 ; Serial No. 50066722610004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610005" ; Lot No. 66722610 ; Serial No. 50066722610005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611001" ; Lot No. 66722611 ; Serial No. 50066722611001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611002" ; Lot No. 66722611 ; Serial No. 50066722611002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611003" ; Lot No. 66722611 ; Serial No. 50066722611003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611004" ; Lot No. 66722611 ; Serial No. 50066722611004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611005" ; Lot No. 66722611 ; Serial No. 50066722611005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611006" ; Lot No. 66722611 ; Serial No. 50066722611006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611007" ; Lot No. 66722611 ; Serial No. 50066722611007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611008" ; Lot No. 66722611 ; Serial No. 50066722611008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611009" ; Lot No. 66722611 ; Serial No. 50066722611009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611010" ; Lot No. 66722611 ; Serial No. 50066722611010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892001" ; Lot No. 66742892 ; Serial No. 50066742892001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892002" ; Lot No. 66742892 ; Serial No. 50066742892002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892003" ; Lot No. 66742892 ; Serial No. 50066742892003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892004" ; Lot No. 66742892 ; Serial No. 50066742892004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892005" ; Lot No. 66742892 ; Serial No. 50066742892005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892006" ; Lot No. 66742892 ; Serial No. 50066742892006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892007" ; Lot No. 66742892 ; Serial No. 50066742892007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892008" ; Lot No. 66742892 ; Serial No. 50066742892008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892009" ; Lot No. 66742892 ; Serial No. 50066742892009 Model No. 60500010100 ; UDI "(01)00889024626454(11…
UPC codes
00889024626454, 50066722609001, 50066722609002, 50066722609003, 50066722609004, 50066722609005, 50066722610001, 50066722610002, 50066722610003, 50066722610004, 50066722610005, 50066722611001, 50066722611002, 50066722611003, 50066722611004, 50066722611005, 50066722611006, 50066722611007, 50066722611008, 50066722611009

Products covered by this recall

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

Check your product

The notice names 26 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00889024626454
  • 50066722609001
  • 50066722609002
  • 50066722609003
  • 50066722609004
  • 50066722609005
  • 50066722610001
  • 50066722610002
  • 50066722610003
  • 50066722610004
  • 50066722610005
  • 50066722611001
  • 50066722611002
  • 50066722611003
  • 50066722611004
  • 50066722611005
  • 50066722611006
  • 50066722611007
  • 50066722611008
  • 50066722611009

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 66722609
  • 66722610
  • 66722611
  • 66742892

Model or item number

On the rating label, the box or the instruction sheet.

  • 60500010100 Software Version
  • 60500010100

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Zimmer Surgical Inc — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Zimmer Surgical Inc — 200 W Ohio Ave, Dover, OH, 44622-9642

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Zimmer Surgical Inc medical devices recalled?

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located. Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00889024626454, 50066722609001, 50066722609002; lot code 66722609, 66722610, 66722611; model number 60500010100 Software Version, 60500010100. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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