Novadaq Spy-Phi Drape Recall: Pinhole Risk Breaches Sterile Barrier
Novadaq recalls sterile surgical drapes with potential pinholes that could breach sterile barriers during medical procedures. Affected units include specific model and lot numbers.
Lower-risk recall
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Contact the company
What happened, in plain English
Novadaq is recalling sterile surgical drapes that may have pinholes, which could compromise the sterile barrier during medical procedures. This poses a risk of infection if the drape is used improperly. Read more at govinfonow.com/recall/73548-novadaq-spy-phi-drape-recall-pinhole-risk-breaches-sterile-barrier.
Source Summary by GovInfoNow · govinfonow.com/recall/73548-novadaq-spy-phi-drape-recall-pinhole-risk-breaches-sterile-barrier · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3234-2017
Cite this page
“Novadaq Spy-Phi Drape Recall: Pinhole Risk Breaches Sterile Barrier.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73548-novadaq-spy-phi-drape-recall-pinhole-risk-breaches-sterile-barrier. Based on FDA recall #Z-3234-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3234-2017%22&limit=1).
Why it’s dangerous
The drape material might have a pinhole that breaks the sterile barrier. This could allow contamination during surgery or medical procedures if the drape is used without a complete sterile seal.
Who’s affected
Healthcare professionals using the drape for surgical procedures are most at risk. Patients are not directly affected as the drape is not meant for patient contact.
How to tell if you have this one
Check for the model number HH2000 on the drape, which is 7" x 104" (18 cm x 265 cm). The lot number 1704121 is also associated with this recall.
- Brand
Novadaq- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3234-2017 | NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), 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.; Lot number 1704121 | 6 drapes |
| Z-3235-2017 | NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. 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.; PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251. | 16/6-drape kits |
| Z-3236-2017 | 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.; Lots #1703291, #1704141, and #1704101 | 3/20-drape boxes |
What to do — step by step
Check Drape Model
Look for the model number HH2000 on the drape, which is 7" x 104" (18 cm x 265 cm).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA distribution: “Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Idaho, Illinois, New York, Oregon, Virginia.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this drape safe for patient use?
No, the drape is not intended for patient contact and is only for covering the SPY-PHI System during medical procedures.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3234-2017 (June 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3234-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.