MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking
MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Under the severity rubric, an FDA Class II recall involving a structural defect in a medical device used during surgery is rated as Severe (4), as it poses a significant risk of injury or procedural failure.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling 37 units of the MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula. The recall was initiated due to complaints that the cannula bent or broke during surgical procedures.
The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico), Australia, Bangladesh, the Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey. The specific lot codes involved are 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.
Healthcare facilities and consumers should stop using the affected cannulas immediately and contact MicroAire Surgical Instruments for instructions on return or replacement.
The recalled product
- Product
- MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Hazard
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 0913228216
- 0414243005
- 0215266350
- 0415269875
- and 0515271334.
Distribution
Related recalls
Same manufacturer · MicroAire Surgical Instruments, LLC
See all →- HighSmartRelease Onyx Blade Assembly Surgical System Recalled
FDA (Devices) · 2025-06-18
- HighMicroAire SmartRelease Endoscopic Carpal Tunnel Handpiece Recall
FDA (Devices) · 2019-08-14
- ModerateMicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2018-06-13
- HighMicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion
FDA (Devices) · 2018-02-07
- ModerateMicroAire K-Wires Recalled for Incorrect Product Labeling
FDA (Devices) · 2017-03-15
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- HighMicroAire PAL-R4011XL Cannula Recalled Due to Breakage During Surgery
FDA (Devices) · 2016-04-13
- HighMaquet Aortic Arterial Cannula Recall Due to De-airing Plug Breakage Risk
FDA (Devices) · 2018-06-20
- HighSorin FlexFlow Venous Cannula Recalled for Sharpness Defect
FDA (Devices) · 2017-11-15
- HighVersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect
FDA (Devices) · 2023-05-03
- ModerateKimberly-Clark Radiofrequency Cannula Recalled for Incorrect Active Tip Length
FDA (Devices) · 2014-02-05
- ModerateSurgical Instrument Recall Due to Compromised Sterile Seal
FDA (Devices) · 2013-07-10