Recall archive
126 recalls · page 3 of 6
Reported Jul 2, 2025
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 21, 2025
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Three is the potential for the retractors to puncture through the sterile packaging.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Reason for recall — A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled…
FDA (openFDA device enforcement)
Reported May 7, 2025
Medline Sterile Water, USP, 100mL, REF RDI30295
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — 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…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
33 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Medline medical procedure kits, containing Medtronic Aortic Root Cannula
10 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
28 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Potential breach in pouch packaging which could lead to loss of sterility.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 8, 2025
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2025
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Reason for recall — Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Product has been identified as having holes in the packaging.
33 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
MEDLINE HEART CABG CDS, REF CDS983376R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential…
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality…
105 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality…
54 more products in this recall
FDA (openFDA device enforcement)
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