The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0156-2022·Announced 2021-10-27

Medtronic Sterile Surgical Blades Recalled for Tip Breaks and Vibration

Medtronic Xomed, Inc. is recalling 274,991 sterile single-use surgical blades used in ENT surgical procedures due to increased complaints of tip breaks and vibration during use.

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 3/5 (High).

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 is an FDA Class II recall involving surgical blades with reported complaints of tip breaks and vibration that could compromise device performance during procedures. No injuries or hospitalizations are reported in the source, placing this in the 'risk-of-harm' category without reported incidents, which meets the rubric criteria for a High severity rating.

Plain-English summary

Medtronic Xomed, Inc. is recalling 274,991 sterile single-use surgical blades that are used as components in surgical handpieces and systems, including the StraightShot M Series Handpiece, Midas Rex Microsaw, and Triton System. The recall affects 24 different blade product numbers with various configurations and sizes.

The blades are being recalled due to an increase in complaints related to tip breaks and wobble/vibration. These defects could compromise the performance of the surgical instruments during procedures and may pose a risk to patients undergoing ENT and other surgical procedures.

The affected blades have been distributed worldwide, including throughout the United States, Puerto Rico, government and military facilities, and numerous international countries including Canada, Mexico, the United Kingdom, Australia, and many others.

Consumers and healthcare facilities should stop using the affected blade product numbers and contact Medtronic Xomed, Inc. for information regarding replacement or return of recalled products. Healthcare providers should review their inventory and identify affected devices based on the provided reference numbers and lot/serial number information.

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 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF…
Manufacturer
Medtronic Xomed, Inc.
Category
Medical Device — Surgical instruments / ENT
Hazard
Affected units
274,991

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 1882916
  • GTIN/UPN 20763000041223 - Lot/serial numbers 0217968715
  • 0218283722
  • 0218283942
  • 0218356873
  • 0218356874
  • 0218356875
  • 0218623544
  • 0219369113
  • 0219501397
  • 0219700166
  • 0220118673
  • 0220659645
  • 0220784922
  • 0220826101
  • 0220826102
  • 0221020300
  • 0221118606
  • 0221118607
  • 0221118608

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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