Anesthesia sets recalled because they contain recalled leaking Clearlink IV sets
Medline is recalling 950 Adult Anesthesia Sets because specific lots may contain Clearlink IV sets that Baxter recalled following customer reports of leaking.
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: Scored 3 under the risk-of-harm criterion: the kits carry an IV set recalled for leaking, which can interrupt delivery of fluids or medicines, and no injuries are reported.
Plain-English summary
Medline Adult Anesthesia Sets, REF DYNJ39985G, are being recalled because specific items and lots of the kits may contain Clearlink IV sets, which Baxter recalled due to customer reports of leaking.
The recall covers 950 units carrying UDI/DI 10198459062353 for each unit and 40198459062354 for the case, from lot 25GMB464. The product was distributed in Missouri. The FDA has classified the action as Class II.
The enforcement record traces the problem to the component IV set rather than the rest of the kit, and reports no injuries.
Facilities holding the affected lot should quarantine it and follow Medline's instructions.
The recalled product
- Product
- Medline Adult Anesthesia Set, REF DYNJ39985G
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Anesthesia set
- Affected units
- 950
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 (2)
- UDI/DI 10198459062353 (EA) 40198459062354 (Case)
- Lot Numbers: 25GMB464
Distribution
Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls cardiac surgery kits with non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
Same hazard · leak
See all →- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
Similar recalls
- CriticalBreathing kits recalled over cracks in the expandable anesthesia tubing
FDA (Devices) · 2025-11-19
- CriticalAdult anesthesia circuit kits recalled over cracked expandable tubing
FDA (Devices) · 2025-11-19
- CriticalSurgical convenience kits recalled over cracked anesthesia circuit tubing
FDA (Devices) · 2025-11-19
- CriticalOpen heart and vascular kits recalled over cracked anesthesia circuit tubing
FDA (Devices) · 2025-11-19
- CriticalExpandable anesthesia circuits recalled over cracks causing leaks in tubing
FDA (Devices) · 2025-11-19
- CriticalAirway procedure kits recalled over cracks in anesthesia circuit tubing
FDA (Devices) · 2025-11-19