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
Recall database
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Browse 4,420 active product recalls and safety alerts. Use search and filters to narrow the list by product, brand, hazard level, or status.
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- 15
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
HIGH
FDA DEVICE
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
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, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
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 Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer
Five complaints
HIGH
FDA DEVICE
ARTIS icono ceiling. Model Number: 11328100.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Siemens Medical Solutions USA
Potential for
HIGH
FDA DEVICE
RayCare 2024A SP1. 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
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5....
Insulet
External soft
HIGH
FDA DEVICE
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529...
Insulet
External soft
HIGH
FDA DEVICE
ARTIS icono biplane. Model Number: 11327600.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Siemens Medical Solutions USA
Potential for
HIGH
FDA DEVICE
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single...
Insulet
External soft
HIGH
FDA FOOD
ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP...
Refresqueria Estrella
Undeclared FD&C
HIGH
FDA DEVICE
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A,...
W L Gore & Associates
Due to
HIGH
FDA DEVICE
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. ...
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
DEPUY
The external
HIGH
FDA DEVICE
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
Medtronic Navigation, Inc.-Boxborough
Potential for