Medical DeviceNov 2, 2022
W L Gore & Associates GORE CARDIOFORM ASD Occluder. cardiovascular implant recall — FDA Z-0136-2023
Due to manufacturing records (Release Test Results) indicating "Failed".
Class IIFDA: OngoingW L Gore & Associates, Inc.
November 2022 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceNov 2, 2022
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 recall — FDA Z-0124-2023
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceNov 2, 2022
Merit Medical Systems CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B recall — FDA Z-0138-2023
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceNov 2, 2022
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 recall — FDA Z-0121-2023
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceNov 2, 2022
Siemens Medical Solutions USA ARTIS pheno, Interventional fluoroscopic x-ray system, Model recall — FDA Z-0119-2023
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceNov 2, 2022
ZOLL Circulation AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model recall — FDA Z-0118-2023
Due to increase in Li-Ion Battery failures
Class IIFDA: OngoingZOLL Circulation, Inc.
Medical DeviceNov 2, 2022
Encore Medical EMPOWER 3D Knee Tibial Insert, REF: 341-14-708 recall — FDA Z-0126-2023
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 2, 2022
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) recall — FDA Z-0135-2023
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs…
Class IIIFDA: TerminatedLumiraDx
Medical DeviceNov 2, 2022
Angiodynamics Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone recall — FDA Z-0132-2023
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation,…
Class IIFDA: OngoingAngiodynamics, Inc.
Medical DeviceNov 2, 2022
Merit Medical Systems CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B recall — FDA Z-0137-2023
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceNov 2, 2022
Encore Medical EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H recall — FDA Z-0125-2023
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 2, 2022
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 recall — FDA Z-0120-2023
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceNov 2, 2022
Datascope LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. recall — FDA Z-0131-2023
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or…
Class IIFDA: OngoingDatascope Corporation
Medical DeviceNov 2, 2022
Intuitive Surgical da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished recall — FDA Z-0133-2023
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not…
Class IIFDA: OngoingIntuitive Surgical, Inc.
FoodNov 2, 2022
Cut Fruit Express Caribou Coffee Snack Fruit and Cheese Plate, item # 3818, Net recall — FDA F-0117-2023
Brie cheese has the potential to be contaminated with Listeria monocytogenes.
Class IFDA: TerminatedCut Fruit Express, Inc.
FoodNov 2, 2022
THE CHAI BOX CHAI CONCENTRATE 16FL OZ/473ML glass bottles UPC recall — FDA F-0078-2023
Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.
Class IIIFDA: TerminatedThe Chai Box
FoodNov 2, 2022
THE CHAI BOX CHAI CONCENTRATE UNSWEETENED 16FL OZ/473ML glass recall — FDA F-0079-2023
Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.
Class IIIFDA: TerminatedThe Chai Box
FoodNov 2, 2022
Secrets Of The Tribe Amla Alcohol-Free Extract, 2 oz recall — FDA F-0072-2023
Product has elevated level of lead.
Class IIFDA: TerminatedSecrets Of The Tribe
FoodNov 2, 2022
Cuisine Innovations Unlimited Earth Grown Vegan Traditional Falafel NET WT 12 OZ recall — FDA F-0140-2023
Possible presence of Shiga toxin-producing E. coli.
Class IFDA: TerminatedCuisine Innovations Unlimited, LLC
FoodNov 2, 2022
Secrets Of The Tribe Indian Gooseberry Alcohol-Free Extract, 2 oz recall — FDA F-0073-2023
Product has elevated level of lead.
Class IIFDA: TerminatedSecrets Of The Tribe
FoodNov 2, 2022
Cuisine Innovations Unlimited Earth Grown Vegan Garlic & Herb Falafel NET WT 12 OZ recall — FDA F-0141-2023
Possible presence of Shiga toxin-producing E. coli.
Class IFDA: TerminatedCuisine Innovations Unlimited, LLC
FoodNov 2, 2022
Tomoorona Qassim Mix for Coffee, Net Weight 125g, packaged in a plastic recall — FDA F-0077-2023
The product is labeled to contain sodium caseinate, a milk derivative, but the label does not declare the product contains "milk."
Class IIFDA: TerminatedTomoorona LLC
DrugNov 2, 2022
Ultra Chem Labs Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills recall — FDA D-0016-2023
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class IIFDA: TerminatedUltra Chem Labs Corp
DrugNov 2, 2022
Exela Pharma Sciences 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL recall — FDA D-0023-2023
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class IFDA: TerminatedExela Pharma Sciences LLC
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.