ProCuity Hospital Beds: Missing electrical safety tests pose burn and shock risk
Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.
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 Class II medical device recall with no reported illnesses or injuries. Although electrical burns and shocks are serious hazards, the source describes these as risks rather than documented incidents. Per the severity rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling ProCuity hospital beds, model 3009 (item number 3009PX-LE-400), due to missing electrical safety test values.
The beds lack required electrical safety testing documentation, presenting a risk of tissue burns or electrical shock to patients. The affected product is identified by UDI-DI (GTIN) 07613327541182.
These beds were distributed nationwide throughout the United States and Puerto Rico, as well as internationally to Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.
The recalled product
- Product
- ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
- 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): 07613327541182. Serial numbers: 2105002838
- 2105002832
- 2202000312
- 2202000286
- 2202000278
- 2202000180
- 2106002241
- 2106001240
- 2107001002
- 2203001053
- 2203001898
- 2112001135
- 2211002054
- 2105002782
- 2210002902
- 2210002890
- 2210002876
- 2210002858
- 2210002848
- 2111001420
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.
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