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Open, Classified

ProCuity bed series, model number 3009, item number: 3009PX-LE-450.

FDA Recall Z-0428-2024 · Posted 2023-12-01

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusOpen, Classified
Product CodeFNL
Date Initiated2023-08-30

Reason for Recall

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Firm Action

A customer notification was sent October 20, 2023 via FedEx. Users are to (1) Locate affected units and identify the address where they can be serviced. (2) Return the business reply form by fax +1 269 488-8691 or email to [email protected]. Upon receipt of the completed business reply form, Stryker will contact you to arrange a time to complete the required electrical tests. (3) Forward notification to any new user/location and advise Stryker of the new address or device status if disposed of or obsolete using the reply form. Address questions or concerns to Customer Service at +1 800 327-0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.

Root Cause

Process control

Distribution Pattern

Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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