MEDLINE INDUSTRIES, Lp - Northfield
United Statesfrom the FDA registration address FDA establishment FEI 1417592
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 812800 ongoing
Company details
- FDA FEI number
- 1417592
- Address
- Three Lakes Drive, Northfield, IL, 60093
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 7
- 2022 108
- 2023 198
- 2024 382
- 2025 117
- 2026 0
2025
- 25 Jul 2025 Z-2566-2025 Class I Ongoing 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.
- 25 Jul 2025 Z-2567-2025 Class I Ongoing 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.
- 23 Jul 2025 Z-2479-2025 Class II Ongoing 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).
- 14 Jul 2025 Z-2460-2025 Class I Ongoing Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
- 8 Jul 2025 Z-2452-2025 Class II Ongoing 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.
- 16 Jun 2025 Z-2199-2025 Class II Ongoing 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.
- 12 Jun 2025 Z-2153-2025 Class II Ongoing 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.
- 12 Jun 2025 Z-2154-2025 Class II Ongoing 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.
- 12 Jun 2025 Z-2155-2025 Class II Ongoing 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.
- 12 Jun 2025 Z-2156-2025 Class II Ongoing 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.
Show the 25 most recent of 812 recalls
2025
- 23 May 2025 Z-2043-2025 Class II Ongoing 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.
- 23 May 2025 Z-2044-2025 Class II Ongoing 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.
- 23 May 2025 Z-2045-2025 Class II Ongoing 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.
- 15 May 2025 Z-1995-2025 Class II Ongoing There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
- 22 Apr 2025 Z-1809-2025 Class I Ongoing Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- 22 Apr 2025 Z-1810-2025 Class I Ongoing Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- 22 Apr 2025 Z-1811-2025 Class I Ongoing Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- 9 Apr 2025 Z-1765-2025 Class II Ongoing Three is the potential for the retractors to puncture through the sterile packaging.
- 9 Apr 2025 Z-1766-2025 Class II Ongoing Three is the potential for the retractors to puncture through the sterile packaging.
- 24 Mar 2025 Z-1719-2025 Class II Ongoing A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
- 19 Mar 2025 Z-1705-2025 Class II Ongoing It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- 19 Mar 2025 Z-1706-2025 Class II Ongoing It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- 19 Mar 2025 Z-1707-2025 Class II Ongoing It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- 19 Mar 2025 Z-1708-2025 Class II Ongoing It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- 19 Mar 2025 Z-1709-2025 Class II Ongoing It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.