Hospital mattresses recalled because they are not tested with certain beds
Stryker is recalling 297 Arise 1000EX mattresses because they and certain MV3 beds have been sold in close proximity, and the two products have not been tested for compatibility.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an untested product combination with no stated defect, consequence or reported harm.
Plain-English summary
The Stryker Arise 1000EX mattress, part number 2236000000, is being recalled by the Stryker Medical Division of Stryker Corporation.
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. The firm states these products have not been tested for compatibility and are not designed to be used together, and that the combination of both is not recommended by Stryker.
The recall covers 297 units carrying GTIN 00857268006608, with affected serial numbers listed in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes an untested product pairing rather than a defect in either item, and states no injuries. Facilities should follow Stryker's instructions.
The recalled product
- Product
- Stryker Arise 1000EX mattress, Part Number 2236000000
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital bed
- Affected units
- 297
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)
- GTIN 00857268006608
- Serial Numbers: 1000502893
- 1000281054
- 1000281055
- 1000281056
- 1000213521
- 1000213522
- 1000213529
- 1000213530
- 1000213531
- 1000213532
- 1000213533
- 1000214321
- 1000214331
- 1000377179
- 1000377180
- 1000377181
- 1000382290
- 1000382291
- 1000382292
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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