FDA Medical Device Recalls (openFDA)
MicroAire Surgical Instruments, LLC: MicroAire PAL Cannula Product Usage - Power Aspiration Device
- Recall number
- Z-1328-2016
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Product
- MicroAire PAL Cannula Product Usage - Power Aspiration Device
- Status
- Terminated
- Initiated
- 2016-02-08
- Posted
- not on file
- Terminated
- 2017-02-14
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm is sending letters to all customers who have received PAL-R4011XL from August 2013- October 2015. The firm sent these letters by UPS to expedite the delivery and for traceability.
- Quantity
- 145 manufactured and distributed
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEA
- Firm FEI
- 2020601
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28