Stryker 6381 M-1 Cot Fastener Recalled for Missing Manual Warnings
Stryker is recalling three 6381 M-1 Cot Fasteners because their manuals contain incorrect information and missing warnings.
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: The recall is classified as FDA Class II, but the specific hazard is a documentation error (missing warnings/incorrect info) rather than a direct physical defect or reported injury, fitting the 'Minor labeling errors' or 'voluntary precautionary' criteria for a Moderate score.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling three units of the 6381 M-1 Cot Fastener, catalog no. 6381000000. The affected units have serial numbers 170740538, 170740539, and 170740540. The product was distributed to the Netherlands.
The recall is being conducted because the Operations Manual and Maintenance Manual for these devices are missing various warnings and contain incorrect information. This documentation error could potentially lead to improper use or maintenance of the device.
Healthcare facilities that have received these specific serial numbers should stop using the product and contact Stryker for instructions on how to proceed.
The recalled product
- Product
- 6381 M-1 Cot Fastener, catalog no. 6381000000
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 3
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 (1)
- Serial No. 170740538 170740539 170740540
Distribution
Distribution scope not specified by the agency.
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.
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