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Open, Classified

Hobbs Medical Polypectomy Snare, Catalog No. 7202

FDA Recall Z-1388-2022 · Posted None

Recalling FirmHobbs Medical, Inc.
Recall StatusOpen, Classified
Product CodeOCZ
Date Initiated2022-06-03
Product Quantity45 (US)

Reason for Recall

During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.

Firm Action

On June 3, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately cease use of the affected product and to return the product to Hobbs Medical. For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227

Root Cause

Component design/selection

Distribution Pattern

Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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