CooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging
CooperSurgical is recalling 9,400 McKesson Medi-Pak Vaginal Speculums because small-sized speculums were incorrectly packaged in bags labeled for medium-sized speculums.
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 the hazard involves a packaging/labeling error (incorrect size) rather than a direct contamination or structural defect causing immediate severe injury. This aligns with the 'Moderate' criteria for labeling errors or low-risk issues.
Plain-English summary
CooperSurgical, Inc. is recalling 9,400 units of McKesson Medi-Pak Vaginal Speculums, Reorder No. 11-8309. These medical devices are used to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
The recall was initiated because small-sized speculums were incorrectly packaged in printed bags designated for medium-sized speculums. This labeling error could lead to the use of an incorrectly sized instrument during medical procedures.
The affected products were distributed nationwide, including in Illinois, Florida, Georgia, Massachusetts, Missouri, Texas, and Washington. The recall is associated with Work Order 164290. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 9,400
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)
- Work Order:164290
Distribution
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