Z-1323-2016Class II

MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

Name: Z-1323-2016 MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
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: design

FDA source

MicroAire Surgical Instruments, LLC began a recall of MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula on 2016-02-08. FDA classified it as Class II and gives the reason as "Complaints that the cannula bent/broke during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1323-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-08
Posted: 2016-04-05
Terminated: 2016-08-12
Recalling firm: MicroAire Surgical Instruments, LLC
Product: MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Complaints that the cannula bent/broke during surgery.
Root cause tag: design
FDA root cause: Component design/selection
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: 37
Distribution: Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Product codes and lots: 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1323-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-05

Product code BTA

K973268Class IIMicroaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. / cleared 1997-11-26

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)