MicroAire PAL-R4011XL Cannula Recalled Due to Breakage During Surgery
MicroAire is recalling PAL-R4011XL cannulas because three reports indicated the devices bent or broke during surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed during surgery, posing a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
MicroAire Surgical Instruments, LLC has initiated a recall of the PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula). The recall was triggered by the receipt of three complaints stating that the cannulas bent or broke during surgery.
A total of 145 units were manufactured and distributed worldwide, including nationwide in the United States. The affected lot numbers are 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334. The company has placed the product on production hold until further notice.
Healthcare providers and consumers should stop using the affected cannulas and contact MicroAire Surgical Instruments for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Affected units
- 145
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)
- Include lot numbers/serial numbers 0913228216
- 0414243005
- 0215266350
- 0415269875
- 0515271334
Distribution
Distributed nationwide across the United States.
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 · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12