Data Foundry

Medical device recalls 2021

Prime Fifth Wheel Stretcher-stretcher may be used for minor… — Class II medical device recall Z-2207-2021

Ongoing recall by Stryker Medical Division of Stryker Corporation, reported 2021-08-18, distributed nationwide. Medical devices intended for use in a healthcare facility were distributed to residential customers and may be

Recall numberZ-2207-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStryker Medical Division of Stryker Corporation, Portage, MI, United States
Recall initiated2021-05-12
Classified2021-08-06
Reported by FDA2021-08-18
DistributedNationwide (US)
Countries outside the USAR, BR, CA, CL, CO, IN, MX, TH
Quantity3 units
Reason classeslabeling
UPC / GTIN / UDI-DI07613327278149, 07613327278194
Model numbers1105, 1105000000X, 1105000026

Product

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X

Reason for recall

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2207-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.