Surgical convenience kits recalled after being labeled sterile without sterilization process
Medline is recalling 22 Major Pack L-F and LB Basic Custom Pack convenience kits that were labeled as sterile but never went through the sterilization process.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Sterile Medline convenience kits sold as MAJOR PACK L-F, model number DYNJ0382730O, and LB BASIC CUSTOM PACK, model number DYNJ61038B, are being recalled because kits labeled as sterile have not gone through the sterilization process.
The recall covers 22 units, including lot 25GBC583 for the Major Pack L-F. The product was distributed in Florida, Maryland, New Jersey and Tennessee. The FDA has classified the recall as Class I.
Because the packs are intended for use in a sterile field, hospitals and surgery centres holding the listed lots should quarantine them immediately, treat any remaining stock as non-sterile regardless of what the label says, and follow Medline's instructions.
The recalled product
- Product
- Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical kit
- Affected units
- 22
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 (8)
- 1) DYNJ0382730O
- UDI-DI: 10198459117992(each)
- 40198459117993(case)
- Lot Number: 25GBC583
- 2) DYNJ61038B
- UDI-DI: 10195327596316(each)
- 40195327596317(case)
- Lot Number: 25GBF720
Distribution
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls cardiac surgery kits with non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
Same hazard · non sterile
See all →- SevereBeekeeper's Naturals saline nasal spray recalled for microbial contamination
FDA (Drugs) · 2026-06-17
- HighMedline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline medical convenience kits recalled for non-sterile alcohol prep pads
FDA (Devices) · 2026-05-06
Similar recalls
- HighMedline convenience kits recalled for potential use of non-sterile product
FDA (Devices) · 2024-10-30
- HighMedline Medical Procedure Convenience Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline medical procedure kits recalled due to potential non-sterile product risk
FDA (Devices) · 2024-10-30
- ModerateMedline Convenience Kits surgical packs sterilization calibration recall
FDA (Devices) · 2026-05-13
- HighMedline Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
- HighMedline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
FDA (Devices) · 2024-10-30