DrugOct 13, 2021
AMIVAS (US) Artesunate for Injection, 110 mg/vial recall — FDA D-0002-2022
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class IIFDA: TerminatedAMIVAS (US), LLC
October 2021 recalls — page 10
These records include useful source details for the selected month.
DrugOct 13, 2021
Akorn Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper recall — FDA D-0004-2022
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class IIFDA: TerminatedAkorn, Inc.
DrugOct 13, 2021
Firvanq recall — FDA D-0003-2022
Product Mix-up: Incorrect diluent component included in the kit.
Class IFDA: TerminatedAzurity Pharmaceuticals, Inc.
DrugOct 13, 2021
Alpha-Tek ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch recall — FDA D-0001-2022
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class IFDA: OngoingAlpha-Tek LLC
VehicleOct 13, 2021
Hyundai Motor front recall — NHTSA campaign 21V796000
Hyundai Motor America (Hyundai) is recalling certain 2021 Elantra, Elantra HEV, Venue, Genesis GV80 and 2022 Genesis GV70 vehicles. In the event of a crash, the front driver-side and/or…
frontHyundai Motor America
Medical DeviceOct 6, 2021
GE Healthcare Flow sensors kept as stand-alone user replaceable spare parts for the GEHC recall — FDA Z-2595-2021
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceOct 6, 2021
B. Braun Medical Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for recall — FDA Z-2545-2021
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 6, 2021
B. Braun Medical Outlook Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE Y-Sites recall — FDA Z-2546-2021
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 6, 2021
B. Braun Medical OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the recall — FDA Z-2556-2021
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 6, 2021
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions recall — FDA Z-2563-2021
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Class IIFDA: OngoingElekta Inc.
Medical DeviceOct 6, 2021
Medline Industries NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF recall — FDA Z-2574-2021
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceOct 6, 2021
Deerfield Imaging Operating room table - Product Usage: intended for use during diagnostic recall — FDA Z-2586-2021
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceOct 6, 2021
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile recall — FDA Z-2604-2021
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Class IIFDA: TerminatedCorin Ltd
Medical DeviceOct 6, 2021
Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and recall — FDA Z-2608-2021
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Class IIFDA: TerminatedCorin Ltd
Medical DeviceOct 6, 2021
Angiodynamics Xcela PICC with PASV Valve Technology/Kit 5 F-55cm recall — FDA Z-2617-2021
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceOct 6, 2021
Aesculap Implant Systems PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US recall — FDA Z-2579-2021
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Class IIFDA: TerminatedAesculap Implant Systems LLC
Medical DeviceOct 6, 2021
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640 recall — FDA Z-2606-2021
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Class IIFDA: TerminatedCorin Ltd
Medical DeviceOct 6, 2021
Hill-Rom OctoStretch with Stretch Leveller - The combination of this products allows the recall — FDA Z-2597-2021
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide…
Class IIFDA: OngoingHill-Rom, Inc.
Medical DeviceOct 6, 2021
Shanghai United Imaging Healthcare Co uMI 550 System - Product Usage: intended to be recall — FDA Z-2593-2021
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Class IIFDA: OngoingShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceOct 6, 2021
Hill-Rom FlexoStretch recall — FDA Z-2598-2021
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide…
Class IIFDA: OngoingHill-Rom, Inc.
Medical DeviceOct 6, 2021
B. Braun Medical Outlook Pump Add-On Set-single use, for use with the Outlook Safety recall — FDA Z-2558-2021
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 6, 2021
B. Braun Medical OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety recall — FDA Z-2554-2021
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 6, 2021
B. Braun Medical V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety recall — FDA Z-2551-2021
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 6, 2021
Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350 recall — FDA Z-2605-2021
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Class IIFDA: TerminatedCorin Ltd
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.