Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential compromise in sterility assurance due to calibration issues, but the source explicitly states all products were exposed to validated sterilization cycles, making this a precautionary recall without reported adverse events.
Plain-English summary
Medline Industries, LP has recalled multiple models of Medline Convenience Kits that are used in gynecological, obstetric, and general surgical procedures. The kits include hysteroscopy packs, vaginal hysterectomy packs, and related surgical convenience kits distributed nationwide and worldwide. A total of 6,676 units have been identified in this recall.
The recall was initiated due to calibration issues identified in the equipment used to sterilize and package these devices. Although 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.
Healthcare providers and facilities that use these kits should discontinue use of the affected lot numbers and contact Medline Industries for further instructions. The FDA classified this as a Class II recall. Patients who have undergone procedures using these kits should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK…
- Manufacturer
- Medline Industries, LP
- Affected units
- 6,676
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) CDS984086I
- UDI-DI: 10195327428006(each)
- 40195327428007(case)
- Lot Number: 23GBE705
- 2) CDS984086I
- Lot Number: 23HBY878
- 3) CDS984086I
- Lot Number: 23IBV204
- 4) CDS984086I
- Lot Number: 24ABO363
- 5) CDS984086I
- Lot Number: 24CBQ563
- 6) DYKMBNDL91A
- UDI-DI: 10195327246891(each)
- 40195327246892(case)
- Lot Number: 22KBH028
- 7) DYKMBNDL91A
- Lot Number: 22KBH032
- 8) DYKMBNDL91A
- Lot Number: 22KBH451
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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