CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Freedomaire(r) Helmet System With Belt recalled by Microtek Medical
Microtek Medical is recalling Freedomaire(r) Helmet System With Belt, distributed nationwide in the US. The recall was initiated on 10 Mar 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-1340-2015
- FDA event ID
- 70721
- Recalling firm
- Microtek Medical, Columbus, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2015
- FDA classified
- 27 Mar 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 10 Mar 2015 | Recall initiated by company | |
| 27 Mar 2015 | Classified by FDA | +17 days |
| 8 Apr 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
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
Where it was distributed
US (nationwide) Distribution.
Questions about this recall
Why was it recalled?
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Which lots are affected?
Lot Numbers: C9272 and C10078
Where was it sold?
US (nationwide) Distribution.
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
12 other products · FDA event 70721This product is part of a recall event; the main page for the event is Vacuum Tubing 7/8" X 6' X recalled by Microtek Medical.
More recalls from Microtek Medical
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|---|---|---|---|---|---|
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| Device | CLASS II | Transfer Device recalled by Microtek Medical | Microtek Medical | Sterility | Nationwide |
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| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
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