Z-1388-2022 Class II Ongoing
FDA device recall Z-1388-2022 was initiated by Hobbs Medical, Inc. on Jun 3, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 45 (US).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- Jun 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 (US)
Product Description
Hobbs Medical Polypectomy Snare, Catalog No. 7202
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.
Distribution Pattern
Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.
Code Information
UDI-DI: M84972020 Package UDI: M84972021 Lots: H11-20-017 H04-20-062 H04-19-056 H11-19-077 H08-17-014R H10-17-089R H10-17-089 H0S-17-014 H06-17-167
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1388-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026