Medline Recalls Anti-Fog Solution in Surgical Kits Due to Degradation
Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that no illnesses or injuries have been reported. The hazard is a functional failure (failure to defog) rather than a direct health risk, fitting the criteria for a moderate severity score.
Plain-English summary
Medline Industries, Inc. is recalling 14,550 units of anti-fog solution packaged in Tyvek peel pouches. This solution is included in various surgical kits, including those for robotic general surgery, laparoscopic cholecystectomy, and general laparoscopy. The recall is due to a degradation in the chemical properties of the solution, which may cause it to not defog properly.
The affected products were distributed nationwide to 37 states and the District of Columbia, as well as to Canada and Malaysia. The anti-fog solution has a component number of 80532/NONFB100B and an expiration date of 12/2020. Specific material lot numbers and impacted kit lot numbers are listed in the official recall documentation.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. Users should stop using the affected anti-fog solution and contact Medline Industries for further instructions.
The recalled product
- Product
- Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN…
- Manufacturer
- Medline Industries, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 14,550
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)
- Fog solution Component Number: 80532/NONFB100B
- Material Lot Number: 41186649M
- 41186673M
- 41211955M
- 41186657M
- 41236925M
- 41186665M
- DYNJ904625B (19CBA697)
- DYNJ42835A (19CBA118)
- DYNJ39685A (19BBH495)
- DYNJ32935C (19BBE174)
- DYNJ36418F (19ABN461)
- DYNJ50765B (19BBJ183)
- DYNJ47704C (19BBE810)
- DYNJ0862775N (19CBA813)
- DYNJ43628A (19BBG651)
- CDS984674C (19CBA033)
- CDS984659K (19BBT877)
- CDS984656L (19ABO984)
- DYNJ0665310C (19CBG762)
Distribution
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 · functional failure
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighBaxter TruSystem 7500 Hybrid software issue disables upper back adjustment
FDA (Devices) · 2025-04-02
- HighSoftware Malfunction Disables Back Control on Baxter TruSystem 7500
FDA (Devices) · 2025-04-02
- SevereCardiac catheters recalled due to polyurethane layer delamination defects
FDA (Devices) · 2024-05-22
Similar recalls
- HighMedline Recalls Non-Sterile Laparoscopy CDS Kits Due to Sterilization Error
FDA (Devices) · 2018-09-12
- HighMedline Surgical Procedure Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2025-04-02
- HighMedline procedure kits recalled for syringe quality defects
FDA (Devices) · 2025-04-02
- HighMedline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues
FDA (Devices) · 2025-04-02
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02
- HighMedline procedure kits with defective plastic syringes recalled due to leak and breakage risk
FDA (Devices) · 2025-04-02