Stryker Recalls Spy-Phi Drapes Packaged in Unsealed Pouches
Stryker is recalling 21,078 units of Spy-Phi Drapes because they 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 FDA Class II classification indicates a reasonable probability of adverse health consequences due to compromised sterility, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 21,078 units of Spy-Phi Drape (HH2020) packs. The recall is due to the sterile drapes being packaged in unsealed pouches, which compromises the sterility of the medical device.
The affected product is the Spy-Phi Drape only (HH2020) Pack of 20 HH2000, sold internationally. The distribution pattern includes the United States (Nationwide & Puerto Rico) and numerous international locations including the Netherlands, Spain, Switzerland, Colombia, Canada, Japan, and others. The recall covers specific lot numbers ranging from 1703011 to 1908151.
Healthcare facilities and consumers should stop using the affected drapes and contact Stryker Corporation for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Surgical Drapes
- Affected units
- 21,078
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 - 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.
See all 2 products in this recall →Related recalls
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