Progressive Medical Recalls Endoscopic Dissectors with Broken Sterile Seals
Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors because some sterile packages had broken seals, potentially compromising sterility.
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 potential loss of sterility due to broken seals. No illnesses or injuries are reported, and the risk is considered moderate rather than severe.
Plain-English summary
Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors with Kittner Tip (5mm x 40cm), Reorder Number PMILK40. The recall is due to some sterile packages having broken seals, which may compromise the sterility of the devices.
The affected product is Lot 1108-01, distributed nationwide in the United States, including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI. The devices are used for pushing tissue from incisions or wounds during medical procedures such as gynecological laparoscopy and laparoscopic cholecystectomy.
Healthcare facilities and consumers should stop using the affected devices and contact Progressive Medical Inc. for further instructions or a refund.
The recalled product
- Product
- Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive…
- Manufacturer
- Progressive Medical Inc
- Affected units
- 70
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)
- Lot 1108-01
Distribution
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