Medline Surgical Gowns Sterilization Calibration Issues
Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
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: This is an FDA Class II recall involving a medical device with a theoretical risk related to sterilization failure. The source text explicitly states no actual infections, injuries, or adverse events have been reported. The hazard is potential (compromised sterility assurance level) rather than confirmed harm, consistent with a Moderate severity rating.
Plain-English summary
Medline Industries, LP is recalling Medline Surgical Gowns (model DYNJP2001, DYNJP2001S, DYNJP2002, and DYNJP2002S) distributed nationwide in the United States. A total of 70,376,042 units are affected.
The recall was initiated because of identified calibration issues with the equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to compromise the sterility assurance level (SAL) of the recalled products.
Patients and healthcare facilities that have received affected surgical gowns should stop using them immediately. Affected gowns can be identified by their lot numbers, which are listed in detail at the FDA's website. Healthcare providers should contact Medline Industries for instructions on returning or replacing the recalled gowns and obtain replacement products from the manufacturer or authorized suppliers.
The recalled product
- Product
- See complete list in RES, exceeds character limit. Medline Surgical Gowns
- Manufacturer
- Medline Industries, LP
- Affected units
- 70,376,042
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)
- 1) DYNJP2001
- UDI-DI: 10080196073641(each)
- 40080196073642(case)
- Lot Number: 30525050165
- 2) DYNJP2001
- Lot Number: 30525070175
- 3) DYNJP2001
- Lot Number: 30525070223
- 4) DYNJP2001
- Lot Number: 30525100047
- 5) DYNJP2001
- Lot Number: 30525100144
- 6) DYNJP2001
- Lot Number: 30525100377
- 7) DYNJP2001
- Lot Number: 30525020078
- 8) DYNJP2001
- Lot Number: 30525040212
- 9) DYNJP2001
- Lot Number: 30525060247
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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