Medline Sterile Surgical Kits Recalled for Potential Packaging Seal Failure
Medline Industries recalls 671 sterile gynecological surgical kits due to potential open or weak seals on packaging breather pouches. Seal failure could compromise product sterility.
What this means for you
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 with no reported illnesses or injuries. However, the defect involves sterile surgical instrument kits where seal failure poses direct risk of microbial contamination and patient infection, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits used for gynecological and hysteroscopy procedures due to potential open or weak seals on breather pouches used for packaging. The affected products include seven models: PERI GYN PACK (Model DYNJ80786), D & C HYSTEROSCOPY PACK (Model DYNJ21937J), VAGINAL HYSTERECTOMY WRH-LF (Model DYNJ41949B), HYSTER/RESECTOSCOPE #78-RF (Model DYNJ21824R), PERI GYN (Model DYNJ67708A), HYSTEROSCOPY PACK (Model DYNJ56417C), and HYSTEROSCOPY PACK CKHA-LF (Model DYNJ51956B). A total of 671 units are affected.
The risk is that open or weak seals on the breather pouches could allow contamination to enter the packaging during storage or transport, potentially compromising the sterility of the surgical instruments and supplies. This could expose patients to infection during gynecological procedures.
The affected products were distributed nationwide in the United States and internationally to Canada, Mexico, Panama, and the U.S. Virgin Islands. Healthcare facilities should identify affected units using the lot numbers associated with each model and quarantine them pending further instruction from the manufacturer.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PE
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-seal-failure
- contamination-risk
- infection-risk
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) DYNJ80786
- UDI-DI: 10195327079451(each)
- 40195327079452(case)
- Lot Number: 24IBH305
- 2) DYNJ21937J
- UDI-DI: 10195327694876(each)
- 40195327694877(case)
- Lot Number: 24JBN378
- 3) DYNJ41949B
- UDI-DI: 10195327128937(each)
- 40195327128938(case)
- Lot Number: 24JBT902
- 4) DYNJ21824R
- UDI-DI: 10195327107758(each)
- 40195327107759(case)
- Lot Number: 24JBU465
- 5) DYNJ67708A
- UDI-DI: 10195327039899(each)
- 40195327039890(case)
- Lot Number: 24JBV636
Distribution
Distributed nationwide across the United States.
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