CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

SmartRelease Endoscopic Carpal Tunnel Release Handpiece recalled

MicroAire Surgical Instruments is recalling SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers, distributed in 26 states. The recall was initiated on 26 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled103

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-2222-2019
FDA event ID: 83283
Recalling firm: MicroAire Surgical Instruments, Charlottesville, VA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2019
FDA classified: 8 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

26 Jun 2019	Recall initiated by company
8 Aug 2019	Classified by FDA	+43 days
14 Aug 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There was a higher than normal incidence rate of the blade not retracting when tightening.

Product as listed by the FDA

SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

Where it was distributed

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.

California Connecticut Florida Georgia Iowa Illinois Indiana Maryland Michigan Minnesota Mississippi Montana North Carolina New Jersey New York Ohio Oregon Pennsylvania South Carolina Tennessee

Questions about this recall

Why was it recalled?

There was a higher than normal incidence rate of the blade not retracting when tightening.

Which lots are affected?

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

Where was it sold?

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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