FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
- Recall number
- Z-1612-2023
- Recalling firm
- Stryker Sustainability Solutions
- Product
- REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
- Status
- Open, Classified
- Initiated
- 2023-04-14
- Posted
- 2023-05-19
- Terminated
- not on file
- Reason
- Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
- Root cause
- Under Investigation by firm
- Action
- On April 14, 2023, Stryker Sustainability Solutions (SSS) issued an "urgent Medical Device Recall" notification via E-Mail. SSS asked consignees to take the following action: 1) Please check your inventory for the devices from the affected lot and remove them from their point of use. Refer to Figure 1 Product Label. 2) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker s Sustainability Solutions Sales Representative c. Fax: 480-763-5345 This form must be completed and returned to Stryker even if no affected product is found. 3) Maintain awareness of this communication internally until all required actions have been completed within your facility. 4) If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form (page 3) and return the completed form either via email to SSSPFA@stryker.com, to their Stryker s Sustainability Solutions sales representative, or via fax to 480-763-5345. Alternatively, provide contact details so Stryker can inform the recipients appropriately. 5) If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned.
- Quantity
- 50 units
- Distribution
- US: WA OUS: None
- Lot, serial or model codes
- Lot # 0000157564, UDI-DI: 00885825013585
- 510(k) numbers
- ["K100909"]
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28