CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
Medline convenience kits containing BD Insyte Autoguard recalled
Medline Industries LP - Northfield is recalling Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters labeled as, distributed nationwide in the US. The recall was initiated on 23 May 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-2044-2025
- FDA event ID
- 97027
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2025
- FDA classified
- 30 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 23 May 2025 | Recall initiated by company | |
| 30 Jun 2025 | Classified by FDA | +38 days |
| 9 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Product as listed by the FDA
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Where it was distributed
US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
Questions about this recall
Why was it recalled?
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Which lots are affected?
1) REF ACC010665: UDI/DI 10195327334918 (each), 40195327334919 (case), Lot Number 24LDA590
Where was it sold?
US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
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.
Other products in this recall event
2 other products · FDA event 97027This product is part of a recall event; the main page for the event is Medline convenience kits containing BD Insyte Autoguard recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline convenience kits containing BD Insyte Autoguard recalled | Medline Industries LP - Northfield | Other | Nationwide | |
| CLASS II | Medline convenience kits containing BD Insyte Autoguard recalled | Medline Industries LP - Northfield | Other | Nationwide |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Heart & Vascular Devices recalls
All 6,217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |