DrugDec 4, 2019
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial recall — FDA D-0521-2020
Crystallization: Presence of visible particulate matter.
Class IIIFDA: TerminatedAuroMedics Pharma LLC
Latest records
Latest recalls — page 1115
The newest recall records with useful source details are listed here.
DrugDec 4, 2019
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial recall — FDA D-0520-2020
Crystallization: Presence of visible particulate matter.
Class IIIFDA: TerminatedAuroMedics Pharma LLC
DrugDec 4, 2019
AVKARE Ranitidine Tablets, USP 150 mg recall — FDA D-0524-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class IIFDA: TerminatedAVKARE Inc.
DrugDec 4, 2019
AuroMedics Pharma Ranitidine Syrup recall — FDA D-0529-2020
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class IIFDA: OngoingAuroMedics Pharma LLC
DrugDec 4, 2019
Avantor Performance Materials Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial recall — FDA D-0575-2020
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class IIFDA: TerminatedAvantor Performance Materials Inc.
VehicleDec 4, 2019
Ford hoses, lines/piping, and fittings recall — NHTSA campaign 19V859000
Ford Motor Company (Ford) is recalling certain 2020 Explorer and Lincoln Aviator vehicles. Over time, the protective sleeve on the vapor fuel line may chafe through the plastic liquid fuel…
hoses, lines/piping, and fittingsFord Motor Company
VehicleDec 2, 2019
Ascent control module (tcm/pcm/tecm) recall — NHTSA campaign 19V855000
Subaru of America, Inc. (Subaru) is recalling certain 2019 Ascent vehicles. The transmission hydraulic sensor may inaccurately measure the hydraulic fluid pressure.
control module (tcm/pcm/tecm)Subaru of America, Inc.
VehicleDec 2, 2019
Subaru of crankcase (pcv) recall — NHTSA campaign 19V856000
Subaru of America, Inc. (Subaru) is recalling certain 2019 Crosstrek, Forester, and Ascent vehicles. The aluminum Positive Crankcase Ventilation (PCV) valve can separate, allowing the…
crankcase (pcv)Subaru of America, Inc.
Medical DeviceNov 27, 2019
Beckman Coulter AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106 recall — FDA Z-0492-2020
Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out…
Class IIFDA: OngoingBeckman Coulter Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0491-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Angiodynamics Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 recall — FDA Z-0411-2020
The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0464-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0474-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0423-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the recall — FDA Z-0416-2020
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is…
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0437-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0433-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0424-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Applied Medical Resources Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook recall — FDA Z-0509-2020
Unintentional shifting of the tip insulation of the firm's electrosurgical probes.
Class IIFDA: TerminatedApplied Medical Resources Corp
Medical DeviceNov 27, 2019
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a recall — FDA Z-0511-2020
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Class IIFDA: TerminatedNeocis Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0446-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0451-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
Medical DeviceNov 27, 2019
AMD Medicom MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 recall — FDA Z-0495-2020
Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask…
Class IIFDA: TerminatedAMD Medicom Inc.
Medical DeviceNov 27, 2019
Cook Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and recall — FDA Z-0454-2020
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Class IIFDA: TerminatedCook Inc.
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