The Recall Desk
HighFDA (Devices)·Z-1388-2022·Announced 2022-07-27

Hobbs Medical Polypectomy Snare May Fail to Close Properly

Hobbs Medical Polypectomy Snares (Catalog No. 7202) may accordion at the proximal end, preventing full closure and potentially causing injury. Specific lots distributed to medical facilities in NC, TX, WA, and Canada 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 is an FDA Class II recall involving a mechanical failure that may prevent proper device closure, creating potential for patient injury. However, no injuries or hospitalizations have been reported in the source, placing this in the High (3) category per the rubric for risk-of-harm products without documented injury.

Plain-English summary

Hobbs Medical, Inc. is recalling the Polypectomy Snare, Catalog No. 7202, a medical device used in endoscopic procedures to remove polyps. The recall affects 45 units distributed to medical facilities in North Carolina, Texas, Washington, and Canada.

The device sheath may accordion at the proximal end where it meets the shrink band. This kinking can prevent the snare from fully closing, creating a potential for injury during clinical use.

Affected lot numbers are: H11-20-017, H04-20-062, H04-19-056, H11-19-077, H08-17-014R, H10-17-089R, H10-17-089, H0S-17-014, and H06-17-167. Medical facilities should verify their inventory against these lot numbers.

The recalled product

Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Manufacturer
Hobbs Medical, Inc.
Hazard
  • mechanical-failure
  • closure-failure

Distribution

Distributed in 3 states:

  • NC
  • TX
  • WA