---
title: "ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support — FDA record Z-0916-2022 | Is It on Recall"
description: "Pouch seals may be open, compromising sterility."
url: https://isitonrecall.com/recall/fda-device-z-0916-2022-rotawire-drive-and-wireclip-torquer-rotawire-drive-extra-support/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support — FDA record Z-0916-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- **Reason**: Pouch seals may be open, compromising sterility.
- **Classification**: Class II
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 488 5-packs
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0916-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0916-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution in the US and territories, Japan, and Canada

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Apr 20, 2022
- **Recall initiation date**: Mar 8, 2022
- **Center classification date**: Apr 12, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0916-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)