Medline Industries, LP
Medline Industries, LP appears in FDA public data with 643 recalls — including 88 Class I (most serious) —, 268 510(k) clearances, 82 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-2737-2026, Class II) was initiated on June 10, 2026. Its most recent 510(k) clearance was granted on June 22, 2026.
Summary
- Total Recalls
- 643 (88 Class I)
- 510(k) Clearances
- 268
- Inspections
- 82
- Compliance Actions
- 4
Known Names
medline industries, medline industries, lp - northfield, medline industries, lp - spt
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2737-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J | June 10, 2026 |
| Z-2736-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 | June 10, 2026 |
| Z-2611-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPE | May 28, 2026 |
| Z-2609-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ90585 | May 28, 2026 |
| Z-2606-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYN | May 28, 2026 |
| Z-2697-2026 | Class II | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PA | May 28, 2026 |
| Z-2608-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE | May 28, 2026 |
| Z-2612-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYN | May 28, 2026 |
| Z-2696-2026 | Class II | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Mo | May 28, 2026 |
| Z-2607-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G | May 28, 2026 |
| Z-2695-2026 | Class II | Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A | May 28, 2026 |
| Z-2613-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS98 | May 28, 2026 |
| Z-2610-2026 | Class II | Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP D | May 28, 2026 |
| Z-2534-2026 | Class II | Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPI | May 21, 2026 |
| Z-2537-2026 | Class II | Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A | May 21, 2026 |
| Z-2544-2026 | Class II | Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 | May 21, 2026 |
| Z-2539-2026 | Class II | Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, | May 21, 2026 |
| Z-2535-2026 | Class II | Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 | May 21, 2026 |
| Z-2533-2026 | Class II | Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universa | May 21, 2026 |
| Z-2540-2026 | Class II | Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 | May 21, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | June 22, 2026 |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99 | March 25, 2026 |
| K251687 | Konig Bell Circumcision Clamp | February 25, 2026 |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | November 20, 2025 |
| K250345 | Medline Bag Decanter | October 24, 2025 |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus | July 2, 2025 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | April 11, 2025 |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | February 26, 2025 |
| K241778 | Hudson RCI Comfort Flo® CubCannula | December 19, 2024 |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (14093 | December 19, 2024 |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | September 27, 2024 |
| K234132 | Medline Reusable Sterilization Wrappers | September 17, 2024 |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | August 2, 2024 |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult | June 4, 2024 |
| DEN210049 | Medline ART Skin Harvesting System | March 27, 2024 |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | March 26, 2024 |
| K233526 | Medline Open-back Level 3 Protective Gown | March 5, 2024 |
| K230235 | Medline Luer Lock Syringes | February 16, 2024 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | January 4, 2024 |
| K231211 | Medline ComfortTemp Patient Warming System | December 1, 2023 |