Berchtold Corp. Recalls OPERON D850 Surgical Tables Due to Malfunction
Berchtold Corp. is recalling 263 OPERON D850 surgical tables because they were not lowering. The units were distributed nationwide in the US and Canada.
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: The recall is classified as FDA Class II and involves a medical device malfunction (failure to lower) that poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Berchtold Corp. is recalling 263 units of the OPERON D850 Surgical Table. The recall was initiated because the tables were not lowering as intended.
The affected surgical tables were distributed nationwide in the United States, including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IL, IA, KY, LA, MD, MA, MI, MN, MS, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, and WI, as well as in Canada.
The FDA has classified this recall as Class II. Users should contact Berchtold Corp. for further instructions regarding the recall.
The recalled product
- Product
- OPERON D850 Surgical Table Product Usage: Surgical Table
- Manufacturer
- Berchtold Corp.
- Category
- Medical Device — Surgical Table
- Hazard
- Affected units
- 263
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)
- 3501110-S10023
- 3501110-S10024
- 3501110-S10025
- 3501110-S10205
- 3501110-S10208
- 3501110-S10064
- 3501110-S10036
- 3501110-S10043
- 3501110-S10045
- 3501110-S10050
- 3501110-S10061
- 3501110-S10062
- 3511110-S10139
- 3511110-S10143
- 3511110-S10144
- 3511110-S10162
- 3501110-S10192
- 3501110-S10018
- 3511110-S10038
- 3511110-S10041
Distribution
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