Anesthesia Turnover Kit with Non-Sterile Mastisol Component Recalled
Medline Industries recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.
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: This FDA Class II recall involves a medical device with a high-risk infection hazard—a non-sterile component in a sterile kit without proper labeling. Although no illnesses or injuries have been reported, the risk-of-harm nature of the product classifies this as High severity per FDA recall criteria.
Plain-English summary
Medline Industries, LP has recalled the Anesthesia Turnover Kit, Pack Number DYNJAA0377. A non-sterile Mastisol component was included in the kit without being labeled as non-sterile. The affected product was distributed to facilities in Texas, Illinois, and California.
The concern is that if a user assumes the Mastisol component is sterile during use, there is an increased risk of patient infection. The component was placed in the non-sterile portion of the kit but lacked clear labeling indicating its non-sterile status.
A total of 105 units were affected by this recall. The affected lot number is 22LBM357 (UDI/DI Case 40195327231126; UDI/DI Each 10195327231125).
The recalled product
- Product
- ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Anesthesia Kit
- Affected units
- 105
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 (3)
- UDI/DI Case 40195327231126
- UDI/DI Each 10195327231125
- Lot Numbers: 22LBM357
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- HighSterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
FDA (Devices) · 2023-12-20
- HighMedline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk
FDA (Devices) · 2024-10-30
- HighMedline Non-Sterile PVP Solution Incorrectly Labeled as Sterile
FDA (Devices) · 2023-07-19
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- SevereMedline Recalls Non-Sterile Urinalysis Kit Specimen Containers
FDA (Devices) · 2024-11-20