FDA Medical Device Recalls (openFDA)
MicroAire Surgical Instruments, LLC: SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
- Recall number
- Z-2222-2019
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Product
- SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
- Status
- Terminated
- Initiated
- 2019-06-26
- Posted
- not on file
- Terminated
- 2020-04-29
- Reason
- There was a higher than normal incidence rate of the blade not retracting when tightening.
- Root cause
- Component change control
- Action
- Urgent Medical Device Recall notification letters were sent to customers on 6/26/19. Additional customers identified later sent letters on 7/17/19. Regardless of the above IFU information, to be on the safe side, MicroAire is performing this recall and asking that you please complete and send back page two of this letter to notification@microaire.com or via fax at 800-648-4309. We will rework the handpiece (by replacing the handpiece head) and return it to you. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of 8:30 AM and 5:00 PM (EST) Monday through Friday.
- Quantity
- 103
- Distribution
- The products were distributed to the following US states: CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Czech Republic, France, Germany, and Taiwan.
- Lot, serial or model codes
- Serial Numbers: 1004 1031 13389 13391 13394 13395 13396 13398 13399 13400 13401 13402 13403 13404 13405 13406 13407 13408 13409 13412 13414 13416 13417 13418 13419 13421 13422 13423 13425 13426 13428 13429 13430 13431 13432 13433 13435 13436 13437 13438 13441 13442 13443 13448 13449 13452 13453 13454 13455 13457 13458 13459 13460 13461 13462 13463 13464 13465 13466 13468 13469 13472 13473 13474 13475 13476 13477 13478 13479 13480 13481 13483 13484 13485 13486 13487 13499 13500 13501 13502 13503 13504 13505 13506 13507 13515 13516 13390 13393 13397 13392 13411 13446 13427 13439 13444 13445 13388 13415 13410 13413 13434 13440
- 510(k) numbers
- ["K912871"]
- PMA numbers
- not on file
- Product code
- HRX
- 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