Zimmer Surgical Inc recalls Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A
Lot / code information
- Lot #
- Code:
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739001"
- Lot #
- 67505739
- Serial #
- 32067505739001
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739003"
- Lot #
- 67505739
- Serial #
- 32067505739003
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739004"
- Lot #
- 67505739
- Serial #
- 32067505739004
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739005"
- Lot #
- 67505739
- Serial #
- 32067505739005
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739006"
- Lot #
- 67505739
- Serial #
- 32067505739006
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739007"
- Lot #
- 67505739
- Serial #
- 32067505739007
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739008"
- Lot #
- 67505739
- Serial #
- 32067505739008
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739010"
- Lot #
- 67505739
- Serial #
- 32067505739010
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739013"
- Lot #
- 67505739
- Serial #
- 32067505739013
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739014"
- Lot #
- 67505739
- Serial #
- 32067505739014
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739015"
- Lot #
- 67505739
- Serial #
- 32067505739015
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739017"
- Lot #
- 67505739
- Serial #
- 32067505739017
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739019"
- Lot #
- 67505739
- Serial #
- 32067505739019
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67505739(21)32067505739020"
- Lot #
- 67505739
- Serial #
- 32067505739020
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816001"
- Lot #
- 67508816
- Serial #
- 32067508816001
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816002"
- Lot #
- 67508816
- Serial #
- 32067508816002
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816003"
- Lot #
- 67508816
- Serial #
- 32067508816003
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816004"
- Lot #
- 67508816
- Serial #
- 32067508816004
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816005"
- Lot #
- 67508816
- Serial #
- 32067508816005
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816006"
- Lot #
- 67508816
- Serial #
- 32067508816006
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816007"
- Lot #
- 67508816
- Serial #
- 32067508816007
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816008"
- Lot #
- 67508816
- Serial #
- 32067508816008
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816009"
- Lot #
- 67508816
- Serial #
- 32067508816009
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816010"
- Lot #
- 67508816
- Serial #
- 32067508816010
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816012"
- Lot #
- 67508816
- Serial #
- 32067508816012
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816013"
- Lot #
- 67508816
- Serial #
- 32067508816013
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816014"
- Lot #
- 67508816
- Serial #
- 32067508816014
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816016"
- Lot #
- 67508816
- Serial #
- 32067508816016
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816017"
- Lot #
- 67508816
- Serial #
- 32067508816017
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816019"
- Lot #
- 67508816
- Serial #
- 32067508816019
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250725(10)67508816(21)32067508816020"
- Lot #
- 67508816
- Serial #
- 32067508816020
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820001"
- Lot #
- 67508820
- Serial #
- 32067508820001
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820002"
- Lot #
- 67508820
- Serial #
- 32067508820002
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820003"
- Lot #
- 67508820
- Serial #
- 32067508820003
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820004"
- Lot #
- 67508820
- Serial #
- 32067508820004
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820005"
- Lot #
- 67508820
- Serial #
- 32067508820005
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820006"
- Lot #
- 67508820
- Serial #
- 32067508820006
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820007"
- Lot #
- 67508820
- Serial #
- 32067508820007
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820008"
- Lot #
- 67508820
- Serial #
- 32067508820008
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820009"
- Lot #
- 67508820
- Serial #
- 32067508820009
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820010"
- Lot #
- 67508820
- Serial #
- 32067508820010
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820011"
- Lot #
- 67508820
- Serial #
- 32067508820011
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820012"
- Lot #
- 67508820
- Serial #
- 32067508820012
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820013"
- Lot #
- 67508820
- Serial #
- 32067508820013
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820014"
- Lot #
- 67508820
- Serial #
- 32067508820014
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820015"
- Lot #
- 67508820
- Serial #
- 32067508820015
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820016"
- Lot #
- 67508820
- Serial #
- 32067508820016
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820017"
- Lot #
- 67508820
- Serial #
- 32067508820017
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820018"
- Lot #
- 67508820
- Serial #
- 32067508820018
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820019"
- Lot #
- 67508820
- Serial #
- 32067508820019
- Model
- 60320010100
- UDI
- "(01)00889024626447(11)250730(10)67508820(21)32067508820020"
- Lot #
- 67508820
- Serial #
- 32067508820020
Show 195 more code fieldsShow fewer
What the firm is doing
On December 30, 2025, the firm began notifying consignees through Urgent Medical Device Recall letters. The firm is conducting this recall in two phases. In Phase 1, which began on 12/30/2025, consignees are informed that the screen may freeze or stop responding to touch when used in certain international languages. Users may continue to use the device by utilizing the English language mode. Use of the device in an affected language is not advised, and may cause the issue to occur. ATS5000 Affected Languages: Czech, Danish, Finnish, French, Italian, Lithuanian, Norwegian, Romanian, Slovak, Slovenian, and Turkish Unaffected Languages: English, Chinese (simplified), Korean, Japanese, Greek, Bulgarian, and Russian All devices manufactured between April 2024 - September 2025 with software version v2.04 are within scope of the recall. Affected devices will require an upgrade to the new software version v2.05 when it is available in early 2026. The firm will issue a removal notice (Phase 2) once the new software version is available. Customers are instructed to not return affected devices before the initiation of Phase 2.
DistributionShow detailsHide
International distribution to the countries of Canada and EMEA only.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1202-2026
- FDA 510(k) clearance · K050411The device's official FDA premarket clearance record
- FDA device classification · KCYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.5910The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Zimmer Surgical IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
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 anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
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 anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm