NOVADAQ SPY-PHI Drape — Class II medical device recall Z-3236-2017
Terminated recall by NOVADAQ TECHNOLOGIES INC., reported 2017-10-04, distributed nationwide. The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the steri
| Recall number | Z-3236-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOVADAQ TECHNOLOGIES INC., Burnaby, N/A, Canada |
| Recall initiated | 2017-06-27 |
| Classified | 2017-09-28 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2017-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, LT |
| Reason classes | sterility |
| Lot numbers | 1703291, 1704101, 1704141 |
| Model numbers | 2020 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3236-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.