ProCurity hospital beds recalled for missing electrical safety testing
Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
What this means for you
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: This is a risk-of-harm medical device where electrical shock and tissue burn are potential hazards, but no patient injuries or illnesses have been reported. FDA Class II recalls without reported harm typically fall within the High severity range.
Plain-English summary
Stryker Corporation is recalling certain ProCurity bed series, model number 3009 (item number 3009PX-ZMX-600), due to missing electrical safety test data. The beds lack documented verification that they meet electrical safety standards and therefore present a potential risk of electrical shock or tissue burn to patients.
The affected beds were distributed nationally in the United States including Puerto Rico, and internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Specific serial numbers are associated with this recall and can be verified through the FDA or the manufacturer.
Facilities using the recalled beds should contact Stryker Medical Division for instructions regarding replacement or corrective action. The FDA has classified this as a Class II recall. Direct inquiries to the manufacturer or FDA for additional information about the affected serial numbers and recommended actions.
The recalled product
- Product
- ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Beds
- Hazard
- electrical-shock
- burn-injury
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)
- UDI-DI (GTIN): 07613327541328. Serial numbers: 2209001834
- 2209001941
- 2209001939
- 2211002329
- 2211002319
- 2211000556
- 2205000776
- 2106000019
- 2202002062
- 2106001528
- 2106001515
- 2209001539
- 2203000249
- 2106002482
- 2202001091
- 2203000298
- 2203000098
- 2108000232
- 2208000679
- 2110000200
Distribution
Distributed nationwide across the United States.
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