# FDA recall Z-3236-2017

> **NOVADAQ TECHNOLOGIES INC.** · Class II · device recall initiated 2017-06-27.

## Product

NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.    The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

## Reason for recall

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

## Distribution

Worldwide Distribution. US (nationwide) to states of:  CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.

## Key facts

- **Recall number:** Z-3236-2017
- **Recalling firm:** NOVADAQ TECHNOLOGIES INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-27
- **Report date:** 2017-10-04
- **Termination date:** 2017-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burnaby, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3236-2017

## Citation

> AI Analytics. FDA recall Z-3236-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3236-2017. Source: US FDA. Licensed CC0.

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