CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Medline Adult Anesthesia Set recalled by Medline Industries
Medline Industries is recalling Medline Adult Anesthesia Set, distributed nationwide in the US. The recall was initiated on 10 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0137-2026
- FDA event ID
- 97650
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Sep 2025
- FDA classified
- 10 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 10 Sep 2025 | Recall initiated by company | |
| 10 Oct 2025 | Classified by FDA | +30 days |
| 22 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Medline Adult Anesthesia Set, REF DYNJ39985G
Where it was distributed
US Nationwide distribution in the states of MO.
Questions about this recall
Why was it recalled?
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
Which lots are affected?
UDI/DI 10198459062353 (EA) 40198459062354 (Case), Lot Numbers: 25GMB464
Where was it sold?
US Nationwide distribution in the states of MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medline Industries
All 709| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |