Medline Convenience Kits recalled due to sterilization equipment calibration issues
Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving sterile medical devices used in surgical procedures (chest tube insertion, hernia repair). The potential compromise of sterility assurance level on surgical kits presents a significant risk of infection and harm, meeting the Class II with significant injury/harm-risk threshold for a Severe rating.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, including the Chest Tube Insertion Tray (Model DYNDA2941A), Chest/Breast-LF (Model DYNJ83950), and Hernia Repair Tote (Models DYNJ908337A and DYNJ908337C). A total of 892 units have been distributed nationwide.
The recall was initiated because of calibration issues identified in the equipment used to sterilize and package these 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.
Healthcare facilities and individuals who received these kits should immediately contact Medline Industries for guidance on next steps. The specific lot numbers affected are detailed in the recall notice.
The recalled product
- Product
- Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 892
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) DYNDA2941A
- UDI-DI: 10195327331795(each)
- 40195327331796(case)
- Lot Number: 23BMB940
- 2) DYNDA2941A
- Lot Number: 23FMF503
- 3) DYNJ83950
- UDI-DI: 10195327318925(each)
- 40195327318926(case)
- Lot Number: 23CBG610
- 4) DYNJ83950
- Lot Number: 23FBF248
- 5) DYNJ83950
- Lot Number: 23LBR075
- 6) DYNJ83950
- Lot Number: 24CBH626
- 7) DYNJ83950
- Lot Number: 24DBT832
- 8) DYNJ908337A
- UDI-DI: 10195327524814(each)
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.
See all 42 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
Same hazard · sterilization failure
See all →- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22