Steris Recalls OT1000 Series Orthopedic Surgical Tables Due to Pivot Pin Issue
Steris is recalling 148 OT1000 Series Orthopedic Surgical Tables because a loose pivot pin assembly may prevent the table from articulating properly.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences or significant injury/property damage reports are assigned a score of 4 (Severe).
Plain-English summary
Steris Corporation is recalling 148 units of the OT1000 Series Orthopedic Surgical Tables, specifically the OT1000, OT1100, and OT1200 models. The recall was initiated after the company identified that the pivot pin assembly located on the table top may become loose. This defect can prevent the surgical table from articulating properly during use.
The affected units were distributed to facilities in the United States, including states such as Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, New York, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, and Virginia. The products were also distributed to foreign accounts in Canada, France, Korea, Panama, Qatar, and Thailand.
The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No specific injuries or illnesses have been reported in the source text.
The recalled product
- Product
- OT1000 Series Orthopedic Surgical Tables
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 148
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 (3)
- OT1000
- OT1100
- and OT1200 Orthopedic Surgical Table
Distribution
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