CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report
T4 Zipper Toga (S/M) recalled by Stryker Instruments Div. of
Stryker Instruments Div. of Stryker is recalling T4 Zipper Toga (S/M), distributed nationwide in the US. The recall was initiated on 23 Feb 2018 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-1505-2018
- FDA event ID
- 79779
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2018
- FDA classified
- 24 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 23 Feb 2018 | Recall initiated by company | |
| 24 Apr 2018 | Classified by FDA | +60 days |
| 2 May 2018 | 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
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Product as listed by the FDA
T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
Where it was distributed
US Nationwide and Ireland, Japan, South Korea, UK
Questions about this recall
Why was it recalled?
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Which lots are affected?
Lot number: 17061794
Where was it sold?
US Nationwide and Ireland, Japan, South Korea, UK
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
10 other products · FDA event 79779More recalls from Stryker Instruments Div. of Stryker
All 161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Triton Sponge System recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | Triton Canister System (finished part numbers FG recalled | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | SurgiCount+ System Application recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | KS, ME |
| Device | CLASS II | Stryker Zyphr Disposable Cranial Perforator recalled | Stryker Instruments Div. of Stryker | Foreign Material | Nationwide |
| Device | CLASS II | Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Other | MI |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |