Schaerer Surgical Table Floor Locking Cylinders Recalled for Leak Risk
Schaerer Medical USA Inc is recalling replacement floor locking cylinders for model 7300 surgical tables because they may leak due to an incorrect O-ring.
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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a mechanical leak, which fits the criteria for a moderate severity recall involving a potential defect without reported harm.
Plain-English summary
Schaerer Medical USA Inc is recalling 10 replacement floor locking cylinders, part number 85118, for the Schaerer model 7300 surgical tables. These cylinders are used to lock the surgical table in place and are contained in the base of the table.
The recall was initiated because the cylinders were manufactured with an incorrect "O" ring, which may cause the cylinder to leak. The affected units have a lot code of 2016-02-01.
The replacement cylinders were distributed worldwide and nationwide in the United States, specifically in the states of California, Connecticut, Florida, Iowa, Indiana, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, and Virginia. The source text does not specify instructions for consumers or healthcare facilities on how to proceed with the recall.
The recalled product
- Product
- Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
- Manufacturer
- Schaerer Medical USA Inc
- Hazard
- Affected units
- 10
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 (2)
- Lot code of the replacement cylinders
- 2016-02-01
Distribution
Part of a larger recall action
This product is one of 2 recalled by Schaerer Medical USA Inc 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
Same manufacturer · Schaerer Medical USA Inc
See all →- ModerateSchaerer 7300 Surgical Tables Recalled for Defective Floor Locking Cylinders
FDA (Devices) · 2016-11-16
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