Medline Convenience Kits Recalled for Potential Open Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits (Model DYNJ80807B, Lot 24IBH993) due to potential open or weak seals on breather pouches used for packaging. Compromised seals may affect product sterility.
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 3/5 (High).
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: FDA Class II recall of sterile medical devices with a contamination/integrity risk (open/weak seals on sterile packaging). The source text does not report any illnesses or injuries, so the hazard is potential rather than confirmed; however, the integrity of sterile medical device packaging represents a risk of harm that justifies a score of 3.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits, specifically the CW PERI GYN model (Model Number DYNJ80807B, Lot Number 24IBH993), due to a potential for open or weak seals on breather pouches used for packaging these sterile medical kits.
The affected kits have been distributed worldwide, including nationwide in the United States and internationally to Canada, Mexico, Panama, and the Virgin Islands. The product is identified by UDI-DI 10195327415624 (each) and 40195327415625 (case).
Consumers and healthcare facilities in possession of affected kits should stop using them and contact Medline Industries for instructions on return or replacement. Open or weak seals on sterile packaging may compromise the sterility of the medical devices contained within.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 48
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 (4)
- 1) DYNJ80807B
- UDI-DI: 10195327415624(each)
- 40195327415625(case)
- Lot Number: 24IBH993
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 34 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · defective seal
See all →- ModerateMedline Non Sterile I&D Kit Procedure Kits Recalled for Leaking Bottles
FDA (Devices) · 2025-05-07
- HighTrader Joe's Solid White Albacore Tuna Recalled for Defective Lid
FDA (Food) · 2025-03-19
- HighClariTEE Probe Ultrasound Recall Due to Defective Epoxy Sealing
FDA (Devices) · 2024-11-06
- HighMedline Surgical Kits Recalled for Weak Seals Compromising Sterility
FDA (Devices) · 2024-07-10
- HighMedline Birthing Room Pack surgical kits recalled due to weak sterile seals
FDA (Devices) · 2024-07-10
Similar recalls
- HighMedline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
FDA (Devices) · 2024-10-30
- HighMedline Medical Procedure Convenience Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised
FDA (Devices) · 2024-10-30
- HighMedline medical procedure kits recalled due to potential non-sterile packaging
FDA (Devices) · 2024-10-30