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
Latest records
Latest recalls — page 403
The newest recall records with useful source details are listed here.
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.
DrugMay 8, 2024
EYLEA recall — FDA D-0479-2024
Lack of Assurance of Sterility: Complaints of syringe breakage
Class IIFDA: TerminatedRegeneron Pharmaceuticals Inc.
DrugMay 8, 2024
Valacyclovir Tablets USP, 500 mg, 90 count bottles recall — FDA D-0481-2024
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class IIIFDA: CompletedViatris Inc.
DrugMay 8, 2024
Hikma Injectables USA Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection recall — FDA D-0480-2024
Labeling: Wrong Barcode
Class IIIFDA: CompletedHikma Injectables USA Inc.
Medical DeviceMay 1, 2024
Covidien Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm recall — FDA Z-1635-2024
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Class IIFDA: OngoingCovidien LP
Medical DeviceMay 1, 2024
Siemens Medical Solutions USA ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791 recall — FDA Z-1599-2024
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceMay 1, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests recall — FDA Z-1636-2024
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results,…
Class IIFDA: OngoingQuidel Corporation
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