CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report
Medical Device Exchange Surgical Gown - Flyte Hood recalled
EXP Pharmaceutical Services is recalling Medical Device Exchange Surgical Gown - Flyte Hood, Tyvek/Mylar, Sterile, Single Use Only, distributed in Arkansas, California, Colorado, District of Columbia, Florida, Texas. The recall was initiated on 11 Feb 2015 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-2211-2015
- FDA event ID
- 71608
- Recalling firm
- EXP Pharmaceutical Services, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Feb 2015
- FDA classified
- 24 Jul 2015
- Reported
- 5 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 11 Feb 2015 | Recall initiated by company | |
| 24 Jul 2015 | Classified by FDA | +163 days |
| 5 Aug 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
Where it was distributed
Distributed in DC and the states of CO, CA, FL, TX, and AR.
Questions about this recall
Is Medical Device Exchange Surgical Gown - Flyte Hood, Tyvek/Mylar, Sterile, Single Use Only recalled?
Yes. EXP Pharmaceutical Services recalled Medical Device Exchange Surgical Gown - Flyte Hood, Tyvek/Mylar, Sterile, Single Use Only on 11 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-2211-2015.
Why was it recalled?
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Which lots are affected?
OEM Catalog number 408-800;
Where was it sold?
Distributed in DC and the states of CO, CA, FL, TX, and AR.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |