CooperSurgical 2 MHz Waterproof OB Probe Recalled for Mislabeling
CooperSurgical is recalling 13 units of 2 MHz Waterproof OB probes because they were incorrectly labeled as 3 MHz probes.
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 and involves a labeling error. Per the rubric, minor labeling errors and voluntary precautionary recalls are rated as Moderate.
Plain-English summary
CooperSurgical, Inc. is recalling 13 units of the 2 MHz Waterproof OB probe. The product is used in obstetrics to detect fetal heart beats. The recall was initiated because the probes were incorrectly labeled as 3 MHz probes.
The affected units were distributed worldwide, including the United States, Canada, and England. Specific serial numbers for the recalled units are listed in the agency documentation.
Healthcare facilities should stop using the affected probes and contact CooperSurgical for instructions on how to return or replace the devices.
The recalled product
- Product
- Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 13
Distribution
Distributed nationwide across the United States.
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