ProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing
Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 product involving electrical safety hazards (electrical shock and tissue burn). The source text does not report any injuries or illnesses, keeping the score at the maximum of 3 per the rubric.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling ProCuity bed series, model number 3009 (item number 3009PX-LEX-450), because the devices are missing test values for electrical safety tests. This missing testing presents a risk of tissue burn or electrical shock to patients.
The affected beds were distributed nationwide in the United States, Puerto Rico, and internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.
Healthcare facilities and patients using these beds should contact Stryker Medical Division immediately for guidance on remediation. The recall affects units with specific serial numbers identified by the manufacturer.
The recalled product
- Product
- ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Beds
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): 07613327541236. Serial numbers: 2207000806
- 2101001244
- 2206000635
- 2206000628
- 2206000626
- 2206000483
- 2206000479
- 2206000412
- 2206000405
- 2206000401
- 2206000177
- 2205000560
- 2107001062
- 2107001046
- 2205000843
- 2205000841
- 2205000840
- 2205000836
- 2205000832
- 2208000197
Distribution
Part of a larger recall action
This product is one of 13 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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