Stryker Recalls Spy-Phi Drapes Due to Unsealed Pouches
Stryker is recalling 26,298 units of Spy-Phi Drapes and Packs because sterile drapes were packaged in unsealed pouches, compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a compromised sterile barrier, which presents a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Corporation is recalling 26,298 units of Spy-Phi Drapes (HH2000) and Spy-Phi Packs (HH9006) sold in the United States and internationally. The recall is due to a defect where sterile drapes were packaged in unsealed pouches. This packaging failure compromises the sterile barrier, posing a risk of infection if the products are used in surgical procedures.
The affected products were distributed nationwide in the US and Puerto Rico, as well as in numerous countries including Canada, Japan, the United Kingdom, and Germany. The recall covers specific lot numbers for the HH2000 drape and broader lot ranges for the HH9006 pack, spanning production dates from 2017 to 2019.
Healthcare facilities and consumers should stop using these products immediately. Stryker advises checking lot numbers against the provided list and contacting the company for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Surgical Drapes
- Affected units
- 26,298
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Impacted Lot Numbers for HH2000 - 1703011
- 1703021
- 1703031
- 1703041
- 1703051
- 1703061
- 1703071
- 1703081
- 1703091
- 1703101
- 1703111
- 1703121
- 1703131
- 1703141
- 1703151
- 1703161
- 1703171
- 1703181
- 1703191
- 1703201
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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