REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular… recallZ-1612-2023 · Stryker Sustainability Solutions · initiated Apr 14, 2023
Class II Open, Classified All recalls posted in May 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected] 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 [email protected], 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.
Recall details
- Recall number
- Z-1612-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2023
- Posted by the FDA
- May 19, 2023
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 50 units
- Product code
- JOW
- FDA submissions
- K100909
- Distribution
- US: WA OUS: None
Product description
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Code information (models, lots, serial numbers)
Lot # 0000157564, UDI-DI: 00885825013585
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/AStryker Sustainability Solutions, Inc. · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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