Medtronic Surgical Blades Recalled Due to Tip Breaks and Vibration
Medtronic is recalling surgical blades used in ENT procedures due to increasing complaints of tip breaks and vibration. Approximately 274,991 devices distributed worldwide are affected.
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: This FDA Class II recall involves surgical instrument failures (tip breaks and vibration) that pose a risk of equipment malfunction during surgical use. No illnesses, injuries, or deaths have been reported, making this a risk-of-harm product without reported harm, qualifying it as High severity per FDA classification criteria.
Plain-English summary
Medtronic Xomed, Inc. is recalling sterile single-use surgical blades used as components in the StraightShot M Series Handpiece, Fusion ENT Navigation Software, Midas Rex Microsaw, and Triton System. The recall was initiated due to an increase in complaints related to tip breaks and wobble/vibration during surgical use.
Approximately 274,991 devices have been distributed worldwide, including throughout the United States, Puerto Rico, and more than 50 countries. These blades are used in ear, nose, and throat (ENT) surgical procedures at healthcare facilities.
This FDA Class II recall affects six specific product numbers with designated lot and serial numbers. Healthcare facilities with these devices should verify their inventory against the affected lots and contact Medtronic Xomed, Inc. for instructions on device replacement or return.
The recalled product
- Product
- Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- tip-break
- vibration
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 (20)
- (1) REF 1883080EM
- GTIN/UPN 00763000034009
- Lot/serial numbers: 0217668426
- 0217668430
- 0217668431
- 0218547904
- 0219386765
- 0219387546
- 0221279639
- 0221597049
- (2) REF 1883480EM
- GTIN/UPN 00763000034016
- Lot/serial numbers: 0218355352
- 0218355353
- 0218355354
- 0218548106
- 0218975242
- 0218975243
- 0219488206
- 0219810719
Distribution
Distributed nationwide across the United States.
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