Medical DeviceMay 8, 2024
RAYSEARCH LABORATORIES AB RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15 recall — FDA Z-1748-2024
Potential for reported SSD to be too high.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
May 2024 recalls — page 15
These records include useful source details for the selected month.
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for recall — FDA Z-1720-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1721-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Zimmer ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for recall — FDA Z-1723-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Noah Medical Galaxy System REF GAL-001 recall — FDA Z-1734-2024
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Class IIFDA: OngoingNoah Medical
Medical DeviceMay 8, 2024
Cardinal Health 200 Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr. recall — FDA Z-1736-2024
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceMay 8, 2024
RAYSEARCH LABORATORIES AB RayStation 9.0.0.113 and 9.0.1.142 recall — FDA Z-1744-2024
Potential for reported SSD to be too high.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceMay 8, 2024
Zimmer ZPLP recall — FDA Z-1716-2024
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the…
Class IIFDA: OngoingZimmer, Inc.
Medical DeviceMay 8, 2024
Cardinal Health 200 Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y recall — FDA Z-1738-2024
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceMay 8, 2024
IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in recall — FDA Z-1708-2024
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class IIFDA: OngoingIVOCLAR VIVADENT AG
Medical DeviceMay 8, 2024
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup recall — FDA Z-1753-2024
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Class IIFDA: CompletedInnomed, Inc.
Medical DeviceMay 8, 2024
RAYSEARCH LABORATORIES AB RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5 recall — FDA Z-1743-2024
Potential for reported SSD to be too high.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceMay 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly recall — FDA Z-1692-2024
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Class IFDA: OngoingThoratec Corp.
Medical DeviceMay 8, 2024
Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 recall — FDA Z-1755-2024
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip,…
Class IIFDA: OngoingJohnson & Johnson Surgical Vision, Inc.
Medical DeviceMay 8, 2024
RAYSEARCH LABORATORIES AB RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89 recall — FDA Z-1750-2024
Potential for reported SSD to be too high.
Class IIFDA: OngoingRAYSEARCH LABORATORIES AB
Medical DeviceMay 8, 2024
Cardinal Health 200 Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr. recall — FDA Z-1735-2024
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceMay 8, 2024
Alere San Diego Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 recall — FDA Z-1702-2024
There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns,…
Class IIFDA: OngoingAlere San Diego, Inc.
Medical DeviceMay 8, 2024
Covidien Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC recall — FDA Z-1731-2024
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Class IIFDA: OngoingCovidien
FoodMay 8, 2024
BF Suma Pharmaceuticals Longreen Corporation 4 in1 Cordyceps Coffee, 18.2 recall — FDA F-1207-2024
Undeclared allergens due to sub-ingredients, soy lecithin and coconut oil
Class IIFDA: TerminatedBF Suma Pharmaceuticals, Inc.
FoodMay 8, 2024
Gracie's Kitchens King Kullen Broccoli Cutlets with Breadcrumbs and Parmesan recall — FDA F-1238-2024
Product contains undeclared wheat and sesame.
Class IFDA: TerminatedGracie's Kitchens Inc.
FoodMay 8, 2024
OS Holding Bottle is labeled as Johnny's Parmesan Garlic Seasoning, 5oz recall — FDA F-1211-2024
Undeclared Sesame. Johnny's Salad & Pasta Elegance product was mislabeled as Johnny's Parmesan Garlic Seasoning. The Johnny's Parmesan Garlic label did not declare sesame, but sesame seeds…
Class IIFDA: TerminatedOS Holding Inc.
FoodMay 8, 2024
Reposteria Artesanal Laura Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding recall — FDA F-1209-2024
Failure to declare FD&C Red #40, Red #3,Yellow #5, Yellow #6, Blue #1 and Blue #2
Class IIFDA: TerminatedReposteria Artesanal Laura
FoodMay 8, 2024
BF Suma Pharmaceuticals Longreen Corporation 4 in1 Reishi Coffee, 18.2 grams/sachet recall — FDA F-1206-2024
Undeclared allergens due to sub-ingredients, soy lecithin and coconut oil
Class IIFDA: TerminatedBF Suma Pharmaceuticals, Inc.
FoodMay 8, 2024
BF Suma Pharmaceuticals Longreen Corporation Xlim Express Coffee, 15 grams/sachet, 10 recall — FDA F-1208-2024
Undeclared allergens due to sub-ingredients, soy lecithin and coconut oil
Class IIFDA: TerminatedBF Suma Pharmaceuticals, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.