CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report
MicroAire PAL¿ Cannula recalled by MicroAire Surgical Instruments
MicroAire Surgical Instruments is recalling MicroAire PAL¿ Cannula, distributed nationwide in the US. The recall was initiated on 8 Feb 2016 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-1328-2016
- FDA event ID
- 73373
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Feb 2016
- FDA classified
- 5 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Feb 2016 | Recall initiated by company | |
| 5 Apr 2016 | Classified by FDA | +57 days |
| 13 Apr 2016 | 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
MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Product as listed by the FDA
MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Which lots are affected?
Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334
Where was it sold?
Worldwide Distribution - US Nationwide
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.
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