Cure Medical Recalls M16 Straight-Tip Intermittent Urinary Catheters Due to Labeling Error
Cure Medical LLC is recalling M16 straight-tip intermittent urinary catheters because some intermediate boxes are mislabeled as M16C coudé-tip catheters.
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 hazard is a labeling error where the product itself is correctly identified on the primary packaging, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Cure Medical LLC is recalling M16, 16Fr, straight-tip intermittent urinary catheters. The recall was initiated because labeling on some of the intermediate boxes incorrectly identifies the contents as M16C coudé-tip catheters, while the actual contents are M16 straight-tip catheters. The individual pouches and case boxes are correctly labeled as M16 straight-tip catheters.
The affected product is identified by Lot 120425. The total affected quantity is 420 cases, which equals 4,200 boxes or 126,000 individual catheters. The product was distributed nationwide. The M16 catheter is intended for male patients for bladder drainage and is manufactured with latex-free, biocompatible materials.
Consumers and healthcare providers should check their inventory for M16 straight-tip catheters with Lot 120425. If the intermediate box label indicates M16C but the pouches contain M16 straight-tip catheters, the product should be returned to Cure Medical LLC or the distributor for replacement or refund. Patients should consult their healthcare provider if they have used the product and have concerns.
The recalled product
- Product
- Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that…
- Manufacturer
- Cure Medical LLC
- Hazard
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 (6)
- Total affected product: M16
- Lot 120425: 420 cases = 4
- 200 boxes = 126
- 4 years and 11 months from the date of packaging. The product
- M16
- is identified with the following UPC Codes for the individual pouches
Distribution
Distributed nationwide across the United States.
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