🔍 RecallPedia

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.

Class I - Dangerous
🏥 Medical Devices Recalled: April 10, 2026 Medline Industries Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25LME383; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25JMJ632; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMI508; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMB093; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25GMB270; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMD040; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMB958; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMD548; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMA551; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24GMI471; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24DBA515; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24BBQ043; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23IBH382; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23GBD403; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 26BMH362; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25LMC760; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25JME361; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25IMI413; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMH140; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMA304; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25GMB268; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25FMF696; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25DMJ266; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB245; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB241; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24GMB114; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24BME560; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25KMD376; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25JMC383; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25FMH538; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24KDB290; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24EDB889; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 23JDC308; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 26ABW292; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25KBT852; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25JBR203; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBS729; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBJ284; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25EBD163; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24EDB670; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24CDA047; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24BDA117; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 23JDB931; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN630; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN631; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU477; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU479; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABQ765; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE062; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE063; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE494; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE495; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE493; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25BBC565; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 24BBP041; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS638; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS639; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23GBC535; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABQ980; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABJ386; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25LBH067; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25KBR359; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25JBP383; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25IBK145; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25ABP041; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24GBD227; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ511; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ026; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24BBP046; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23IBG977; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23GBM182.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medline Industries, LP
Reason for Recall:
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.

Product Codes/Lot Numbers:

Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMH714; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 26AMF179; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25IMI476; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 25GME934; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24JMA156; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 24IMG162; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23IBG784; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBG512; Medline SKU DYNJRA0245: UDI/DI 10884389573488 each, 40884389573489 case, Lot Number 23HBA325; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 26AMK307; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25LME383; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25JMJ632; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMI508; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25IMB093; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25GMB270; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMD040; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 25EMB958; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMD548; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24HMA551; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24GMI471; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24DBA515; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 24BBQ043; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23IBH382; Medline SKU DYNJRA0555: UDI/DI 10888277270923 each, 40888277270924 case, Lot Number 23GBD403; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 26BMH362; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25LMC760; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25JME361; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25IMI413; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMH140; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25HMA304; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25GMB268; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25FMF696; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 25DMJ266; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB245; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24HMB241; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24GMB114; Medline SKU DYNJRA0836A: UDI/DI 10889942833795 each, 40889942833796 case, Lot Number 24BME560; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25KMD376; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25JMC383; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 25FMH538; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24KDB290; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 24EDB889; Medline SKU DYNJRA0978A: UDI/DI 10889942826827 each, 40889942826828 case, Lot Number 23JDC308; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 26ABW292; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25KBT852; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25JBR203; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBS729; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25HBJ284; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 25EBD163; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24EDB670; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24CDA047; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 24BDA117; Medline SKU DYNJRA1034: UDI/DI 10889942760695 each, 40889942760696 case, Lot Number 23JDB931; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN630; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26BBN631; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU477; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABU479; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABQ765; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE062; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 26ABE063; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE494; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE495; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25DBE493; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 25BBC565; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 24BBP041; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS638; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23HBS639; Medline SKU DYNJRA9028: UDI/DI 10884389285701 each, 40884389285702 case, Lot Number 23GBC535; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABQ980; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 26ABJ386; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25LBH067; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25KBR359; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25JBP383; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25IBK145; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 25ABP041; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24GBD227; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ511; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24FBJ026; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 24BBP046; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23IBG977; Medline SKU DYNJRA9030: UDI/DI 10889942785728 each, 40889942785729 case, Lot Number 23GBM182.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2233-2026

Related Recalls

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

Medline Industries

Class I - Dangerous

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 Surgical Instruments Nationwide View Details →

MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.

Medline Industries

Class I - Dangerous

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 Other Medical Devices Nationwide View Details →

MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

Medline Industries

Class I - Dangerous

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

May 4, 2026 Other Medical Devices Nationwide View Details →