CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Lab Kit recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Lab Kit, distributed nationwide in the US. The recall was initiated on 23 Oct 2024 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-0355-2025
- FDA event ID
- 95628
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2024
- FDA classified
- 12 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2024 | Recall initiated by company | |
| 12 Nov 2024 | Classified by FDA | +20 days |
| 20 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Lab Kit, SKU DYLAB1018; Component No. 503581
Where it was distributed
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Nationwide AlabamaCaliforniaFloridaGeorgiaIllinoisKentuckyMissouriMississippiMontanaTennesseeTexasVirginiaWashington
Questions about this recall
Why was it recalled?
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Which lots are affected?
UDI-DI: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246
Where was it sold?
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and 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
7 other products · FDA event 95628| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Urine Collection Vhc recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Clean Catch Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | UA KIT recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Urine Collection Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Urine KIT recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Urine Kit W/bd Cup recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Urinalysis Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | 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 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 |