Z-1328-2016Class II

MicroAire PAL Cannula Product Usage - Power Aspiration Device

Name: Z-1328-2016 MicroAire PAL Cannula Product Usage - Power Aspiration Device
Creator: MicroAire Surgical Instruments, LLC
Published: 2016-02-08
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2016-02-08 / Terminated / root cause: manufacturing process

FDA source

MicroAire Surgical Instruments, LLC began a recall of MicroAire PAL Cannula Product Usage - Power Aspiration Device on 2016-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1328-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-08
Posted: 2016-04-05
Terminated: 2017-02-14
Recalling firm: MicroAire Surgical Instruments, LLC
Product: MicroAire PAL Cannula Product Usage - Power Aspiration Device
Product code: GEA Cannula, Surgical, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 145 manufactured and distributed
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1328-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1328-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code GEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)