Medline Industries, Lp - Northfield
Three Lakes Drive, Northfield, IL, US
Registered product codes
622 product codes
Recent MDR events
328 on file
- BIPOLAR CABLEJul 9, 2026MalfunctionMW5190477
- MEDLINE SILICONE-ELASTOMER COATED LATEX FOLEY CATHETERJul 6, 2026MalfunctionMW5190200
- MEDLINE SILICONE-ELASTOMER COATED LATEX FOLEY CATHETERJul 6, 2026MalfunctionMW5190201
- MICROMIST NEBULIZERJul 6, 2026MalfunctionMW5190247
- MICROMIST NEBULIZERJul 6, 2026MalfunctionMW5190248
- HUBER NEEDLE 19G X0.75Jul 1, 2026MalfunctionMW5190158
- 15 BLADEJun 29, 2026InjuryMW5189973
- MEDLINE PADSJun 23, 2026MalfunctionMW5189838
- MEDLINEJun 9, 2026InjuryMW5189079
- PORT DRESSING KITJun 4, 2026MalfunctionMW5188990
Recalls
812 on file
- Open, ClassifiedSep 19, 2025
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
View FDA record ↗ - Open, ClassifiedSep 19, 2025
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
View FDA record ↗ - Open, ClassifiedAug 28, 2025
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
View FDA record ↗ - Open, ClassifiedAug 28, 2025
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
View FDA record ↗ - Open, ClassifiedAug 27, 2025
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
View FDA record ↗ - Open, ClassifiedJul 30, 2025
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
View FDA record ↗ - Open, ClassifiedJul 21, 2025
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
View FDA record ↗ - Open, ClassifiedJul 21, 2025
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
View FDA record ↗ - Open, ClassifiedJul 21, 2025
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
View FDA record ↗ - Open, ClassifiedJul 21, 2025
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
View FDA record ↗
Compliance history
Matched by FEI 1417592.
FDA inspections
2 on file
- Official Action Indicated (OAI)Jan 22, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 22, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(2)Jan 22, 2024
Individual Report of Malfunction
- 21 CFR 820.30(i)Jan 22, 2024
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Jan 22, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Jan 22, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jan 22, 2024
Lack of or inadequate complaint procedures
Compliance actions
1 on file
Import refusals
2 on file
Top refusal reasons
Compare to industry ↗- Division of Northern Border Imports (DNBI)Feb 13, 2025
80LZA \ GLOVE, PATIENT EXAMINATION, POLY
- Division of Northern Border Imports (DNBI)Feb 13, 2025
80LZA \ GLOVE, PATIENT EXAMINATION, POLY