Medline Recalls Winged Sponges Due to Packaging Seal Voids
Medline Industries is recalling 117,874 units of Winged Sponges Presaturated W/PVP because voids in the packaging seal caused a loss of 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: The recall is classified as FDA Class II, and the hazard involves a loss of sterility in a medical device, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Medline Industries Inc is recalling 117,874 units of Medline Winged Sponges Presaturated W/PVP, reference numbers DYND70289 and DYND70289H, with an expiration date of 06/30/2022. The recall was initiated because voids were discovered in the packaging seal, resulting in a loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
The affected products were distributed nationwide to the following states and districts: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE, and WI.
Consumers and healthcare facilities should check their inventory for the specific reference numbers and expiration date listed above. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, Medline Industries Inc.
The recalled product
- Product
- Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Wound Care
- Affected units
- 117,874
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 (1)
- REF DYND70289 Expiration 06/30/2022
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medline Industries Inc 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 3 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · loss of sterility
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26
Similar recalls
- HighMedline Recalls Surgical Kits Due to Potential Loss of Sterility
FDA (Devices) · 2020-05-27
- HighMedline Swabsticks PVP Product Recalled for Weak Seal Risk
FDA (Devices) · 2024-04-10
- SevereCurad Quick Strip fabric bandages recalled over compromised package seals
FDA (Food) · 2025-12-17
- ModerateMedline Sterile Convenience Kits Recalled for Defective Breather Pouches
FDA (Devices) · 2025-04-23
- HighMedline Dental Pack Recall Due to Breather Pouch Seal Defect
FDA (Devices) · 2022-11-09
- HighMedline PVP Solution Recalled Due to Mislabeled Sterility
FDA (Devices) · 2023-12-20