Z-1771-2022Class II

Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically...

Name: Z-1771-2022 Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically...
Creator: Diversatek Healthcare
Published: 2021-10-29
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2021-10-29 / Terminated / root cause: manufacturing process

FDA source

Diversatek Healthcare began a recall of Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food... on 2021-10-29. FDA classified it as Class II and gives the reason as "M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1771-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-29
Posted: 2022-09-19
Terminated: 2024-04-10
Recalling firm: Diversatek Healthcare Inc
Product: Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.
Product code: FGX Snare, Non-Electrical
Reason for recall: M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.
Root cause tag: manufacturing process
FDA root cause: Employee error
Quantity in commerce: 245 devices
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 00816734021361, lot number 001919, 2024-10-31, shipped between 9-27-2021 and 10-22-2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1771-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1771-2022	Class II	Terminated	Voluntary: Firm initiated	2022-09-28	2022-09-19

Product code FGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)