DrugApr 21, 2021
Riomet recall — FDA D-0334-2021
Microbial Contamination of Non-Sterile Product
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
April 2021 recalls — page 7
These records include useful source details for the selected month.
DrugApr 21, 2021
ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not recall — FDA D-0622-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the…
Class IIFDA: TerminatedNovo Nordisk Inc.
DrugApr 21, 2021
Novo Nordisk OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen recall — FDA D-0617-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the…
Class IIFDA: TerminatedNovo Nordisk Inc.
DrugApr 21, 2021
Asclemed USA Inc. dba Enovachem Pharmaceuticals Distributed by: DocRx, Methylprednisolone recall — FDA D-0330-2021
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Class IIIFDA: OngoingAsclemed USA Inc. dba Enovachem Pharmaceuticals
DrugApr 21, 2021
Spartan Chemical Co foamyiQ Lemon Blossom Hand Sanitizer recall — FDA D-0360-2021
CGMP Deviations
Class IIFDA: TerminatedSpartan Chemical Co Inc.
DrugApr 21, 2021
INSULIN DILUTING MEDIUM FOR NOVOLOG NovoLog FlexPen (insulin aspart) Injection, 100 recall — FDA D-0615-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the…
Class IFDA: TerminatedNovo Nordisk Inc.
DrugApr 21, 2021
Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample recall — FDA D-0618-2021
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the…
Class IIFDA: TerminatedNovo Nordisk Inc.
VehicleApr 21, 2021
XC90 Excellence electrical system software recall — NHTSA campaign 21V273000
Volvo Car USA, LLC (Volvo Car) is recalling certain 2016-2020 XC90 Excellence vehicles. Liquid or condensation on the rear seat control display may cause the front passenger seat to move…
electrical system softwareVolvo Car USA, LLC
VehicleApr 15, 2021
Subaru of electrical system software recall — NHTSA campaign 21V264000
Subaru of America, Inc. (Subaru) is recalling certain 2017-2019 Subaru Impreza and 2018-2019 Crosstrek vehicles. The Engine Control Module (ECM) may continue to power the ignition coil…
electrical system softwareSubaru of America, Inc.
VehicleApr 15, 2021
Subaru of rear recall — NHTSA campaign 21V263000
Subaru of America, Inc. (Subaru) is recalling certain 2018-2019 Subaru Crosstrek, 2019 Crosstrek Hybrid, and 2019 Forester vehicles. The rear stabilizer bracket bolts may loosen and detach.
rearSubaru of America, Inc.
Medical DeviceApr 14, 2021
Fujifilm Medical Systems U.S.A Synapse PACS - Radiological Image Processing System - Product recall — FDA Z-1348-2021
The wrong patient information may be displayed in the viewer or PowerJacket.
Class IIFDA: OngoingFujifilm Medical Systems U.S.A., Inc.
Medical DeviceApr 14, 2021
Tenacore Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an recall — FDA Z-1331-2021
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The…
Class IFDA: TerminatedTenacore LLC
Medical DeviceApr 14, 2021
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for recall — FDA Z-1349-2021
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Class IIFDA: OngoingNuvasive Specialized Orthopedics Inc.
Medical DeviceApr 14, 2021
Integra LifeSciences CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal recall — FDA Z-1354-2021
Incorrect labeling, Catheter did not have the required holes and markings
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceApr 14, 2021
Hologic Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product recall — FDA Z-1369-2021
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceApr 14, 2021
Medtronic Neuromodulation A610 Clinician Programmer Application for Deep Brain Stimulation recall — FDA Z-1368-2021
There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using…
Class IIFDA: OngoingMedtronic Neuromodulation
Medical DeviceApr 14, 2021
Fenwal Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection recall — FDA Z-1345-2021
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
Class IIFDA: TerminatedFenwal Inc.
Medical DeviceApr 14, 2021
Beckman Coulter MicroScan WalkAway-96 plus Instrument recall — FDA Z-1371-2021
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC)…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceApr 14, 2021
Beckman Coulter MicroScan WalkAway-96 plus Reconditioned Instrument recall — FDA Z-1373-2021
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC)…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceApr 14, 2021
Siemens Medical Solutions USA Ysio X.pree recall — FDA Z-1346-2021
A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceApr 14, 2021
NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening System Implant recall — FDA Z-1351-2021
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Class IIFDA: OngoingNuvasive Specialized Orthopedics Inc.
Medical DeviceApr 14, 2021
Tenacore Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 recall — FDA Z-1332-2021
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The…
Class IFDA: TerminatedTenacore LLC
Medical DeviceApr 14, 2021
Heartware Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US recall — FDA Z-1341-2021
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller…
Class IFDA: OngoingHeartware, Inc.
Medical DeviceApr 14, 2021
Fenwal Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the recall — FDA Z-1343-2021
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood…
Class IIFDA: TerminatedFenwal 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.