HIGH
FDA DEVICE
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
Medline Industries, LP
The kits
These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
Immediate attention
High Risk Recalls
4,262 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
- High-risk recalls
- 4,262
- Action level
- Stop use
What to do if you own a recalled product
- Stop using the product immediately
- Keep the product away from children
- Follow the remedy instructions provided
- Contact the manufacturer for a refund or replacement
HIGH
FDA DEVICE
CRE Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific
Potential sterile
HIGH
FDA DEVICE
CRE Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific
Potential sterile
HIGH
FDA DEVICE
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
Medline Industries, LP
The kits
HIGH
FDA DEVICE
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Windstone Medical Packaging
Kits contain
HIGH
FDA DEVICE
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Bard Access Systems
Due to
HIGH
FDA DEVICE
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Windstone Medical Packaging
Kits contain
HIGH
FDA DEVICE
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Baxter Healthcare
There have
HIGH
FDA DEVICE
CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific
Potential sterile
HIGH
FDA DEVICE
CRE Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific
Potential sterile
HIGH
FDA DEVICE
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Medline Industries, LP
The kits
HIGH
FDA DEVICE
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley...
Laborie Medical Technologies
Under extended
HIGH
FDA DEVICE
CRE Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific
Potential sterile
HIGH
FDA DEVICE
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Baxter Healthcare
There have
HIGH
FDA DEVICE
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number:...
Medline Industries, LP
The kits
HIGH
FDA DEVICE
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer
Five complaints
HIGH
FDA DEVICE
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer
Five complaints
HIGH
FDA FOOD
Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag, UPC 8 1000156076 8, 6 bags per case
Hometown Food
Undeclared egg
HIGH
FDA DEVICE
RayCare 2024A SP4. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
RAYSEARCH LABORATORIES AB
Beam set
HIGH
FDA DEVICE
ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Siemens Medical Solutions USA
Potential for