Medline Surgical Drapes Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling multiple models of surgical drapes due to calibration issues with sterilization and packaging equipment that may have compromised the sterility assurance level of the products. All affected units were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving medical devices used in sterile surgical environments. The hazard—compromised sterility assurance—represents a risk of harm in a high-risk setting (surgery), even though no illnesses or injuries have been reported. The source text does not report any adverse events, keeping the score at or below 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling 14,927,765 units of surgical drapes across 53 product models and multiple lot numbers. The drapes include various types used for general surgery, laparoscopy, angiography, orthopedic, and other specialized surgical procedures, as well as veterinary surgical drapes.
Medline identified calibration issues with the equipment used to sterilize and package these devices. Although all recalled products were exposed to validated sterilization and packaging cycles, the calibration defects have the potential to impact the sterility assurance level (SAL) of the products. This raises the possibility that some units may not meet required sterility standards.
The recalled surgical drapes were distributed nationwide in the United States. Healthcare facilities and surgical centers that received these products should stop using them and contact Medline for guidance on replacement or return. Facilities should review their inventory using the provided model numbers and lot numbers to identify affected products.
Patients and healthcare providers with questions about the recall should contact Medline Industries or consult the FDA's official recall notice for detailed product identifiers and lot information.
The recalled product
- Product
- Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5)…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Drapes
- Affected units
- 14,927,765
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) DYNJP2410
- UDI-DI: 10080196739691(each)
- 40080196739692(case)
- Lot Number: 30525050127
- 2) DYNJP2410
- Lot Number: 30525070161
- 3) DYNJP2410
- Lot Number: 30525070250
- 4) DYNJP2410
- Lot Number: 30525060147
- 5) DYNJP2410
- Lot Number: 30522030151
- 6) DYNJP2410
- Lot Number: 30522070033
- 7) DYNJP2410
- Lot Number: 30522080015
- 8) DYNJP2410
- Lot Number: 30522080067
- 9) DYNJP2410
- Lot Number: 30522090028
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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