CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report
T4-Hytrel Zipper Toga recalled by Stryker Instruments Div. of
Stryker Instruments Div. of Stryker is recalling T4-Hytrel Zipper Toga, distributed nationwide in the US. The recall was initiated on 1 Jun 2012 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-1810-2012
- FDA event ID
- 61848
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2012
- FDA classified
- 14 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 1 Jun 2012 | Recall initiated by company | |
| 14 Jun 2012 | Classified by FDA | +13 days |
| 20 Jun 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Where it was distributed
Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Which lots are affected?
Part 0400-821-000, 0400-841-000,and 0400-851-000 all lots
Where was it sold?
Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND
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.
Other products in this recall event
1 other product · FDA event 61848This product is part of a recall event; the main page for the event is T5 Hytrel Zipper Toga recalled by Stryker Instruments Div. of.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | T5 Hytrel Zipper Toga recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS III | Triton Sponge System recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |