CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report
Zimmer Sterile Disposable Tourniquet Cuff recalled by Zimmer Surgical
Zimmer Surgical is recalling Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual, distributed nationwide in the US. The recall was initiated on 3 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1356-2020
- FDA event ID
- 84752
- Recalling firm
- Zimmer Surgical, Dover, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2020
- FDA classified
- 25 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Jan 2020 | Recall initiated by company | |
| 25 Feb 2020 | Classified by FDA | +53 days |
| 4 Mar 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.
Nationwide CaliforniaFloridaIowaIdahoIllinoisLouisianaMassachusettsMissouriNorth CarolinaNew YorkOhioOregonPennsylvaniaSouth CarolinaTennesseeTexasWashingtonWisconsinWest Virginia
Questions about this recall
Why was it recalled?
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Which lots are affected?
Lot 27968701
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer Surgical
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
| Device | CLASS II | Zimmer Dermatome recalled by Zimmer Surgical | Zimmer Surgical | Other | OH |
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