Medline Recalls Surgical Convenience Kits Over Sterilization Calibration Issues
Medline is recalling 12,418 units of various surgical convenience kits due to calibration issues with equipment used for sterilization and packaging, which may affect the sterility assurance level of the devices.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of medical devices where sterilization calibration issues could compromise sterility assurance, posing a risk of infection. Per the rubric, FDA Class II recalls with potential for significant health impact warrant a score of 4 (Severe).
Plain-English summary
Medline Industries, LP is recalling 12,418 units of Medline Convenience Kits used in gynecologic, urologic, and thoracic robotic and laparoscopic procedures. The recall includes 77 distinct kit models with model numbers beginning with CDS, DYKM, DYNJ, and DYNJT prefixes, distributed worldwide including nationwide in the U.S.
The recall is due to calibration issues identified with equipment used to sterilize and package the devices. While all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
The affected products include robotic gynecology, laparoscopy, urology prostate, oncology, and thoracic kits. Healthcare facilities and distributors that received the recalled kits should not use them and should contact Medline for replacement or credit instructions.
Consumers or healthcare providers with questions should contact Medline Industries, LP. The recall was classified as FDA Class II, indicating a device that may cause temporary or medically reversible adverse health consequences if used as intended.
The recalled product
- Product
- Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6)…
- Manufacturer
- Medline Industries, LP
- Affected units
- 12,418
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) CDS982893I
- UDI-DI: 10889942208050(each)
- 40889942208051(case)
- Lot Number: 24IBO240
- 2) CDS983300J
- UDI-DI: 10193489425048(each)
- 40193489425049(case)
- Lot Number: 21CDB781
- 3) CDS984243G
- UDI-DI: 10193489872521(each)
- 40193489872522(case)
- Lot Number: 23CBX440
- 4) CDS984243G
- Lot Number: 23CBN644
- 5) CDS984243G
- Lot Number: 23ABC549
- 6) CDS984243G
- Lot Number: 22OBM422
- 7) CDS984243G
- Lot Number: 22KBD152
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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