DrugAug 26, 2020
CareFusion 213 ChloraPrep With Tint recall — FDA D-1510-2020
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class IFDA: TerminatedCareFusion 213, LLC
August 2020 recalls — page 3
These records include useful source details for the selected month.
DrugAug 26, 2020
Ultra Seal Pain Relief Maximum Strength recall — FDA D-1512-2020
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class IIIFDA: TerminatedUltra Seal Corporation
DrugAug 26, 2020
Calvin Scott & Company Phentermine HCL Blue Speckled tablets, 37.5 mg recall — FDA D-1532-2020
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class IIFDA: TerminatedCalvin Scott & Company, Inc.
DrugAug 26, 2020
Calvin Scott & Company Thyroid 1 Gr tablets, 28-count bags recall — FDA D-1518-2020
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class IIFDA: TerminatedCalvin Scott & Company, Inc.
DrugAug 26, 2020
Calvin Scott & Company Phendimetrazine Yellow Tabs 35mg recall — FDA D-1522-2020
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class IIFDA: TerminatedCalvin Scott & Company, Inc.
DrugAug 26, 2020
Calvin Scott & Company Phentermine HCL Blue/Clear capsules, 30mg recall — FDA D-1528-2020
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class IIFDA: TerminatedCalvin Scott & Company, Inc.
DrugAug 26, 2020
Calvin Scott & Company Phentermine 15mg grey/Yellow Capsules, 28-count bags recall — FDA D-1525-2020
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class IIFDA: TerminatedCalvin Scott & Company, Inc.
VehicleAug 26, 2020
Volkswagen Group of seats recall — NHTSA campaign 20V505000
Volkswagen Group of America, Inc. (Volkswagen ) is recalling certain 2020 Volkswagen Atlas Cross Sport, Jetta, Jetta GLI and Tiguan and Audi Q5 and SQ5 and 2021 Volkswagen Atlas vehicles.…
seatsVolkswagen Group of America, Inc.
VehicleAug 25, 2020
XC60 linkages recall — NHTSA campaign 20V503000
Volvo Car of N.A., LLC (Volvo Cars) is recalling certain 2018-2020 XC60 vehicles. The nuts that secure the front wipers may not have been sufficiently tightened, possibly causing the wipers…
linkagesVolvo Car USA LLC
VehicleAug 21, 2020
Ford critical fasteners recall — NHTSA campaign 20V497000
Ford Motor Company (Ford) is recalling certain 2020 Explorer and 2020 Lincoln Aviator vehicles. The side air bag and/or seat back module attachments may not have been properly tightened in…
critical fastenersFord Motor Company
Medical DeviceAug 19, 2020
Flower Orthopedics Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product recall — FDA Z-2784-2020
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceAug 19, 2020
Ion Beam Applications S.A Proteus 235 The Proton Therapy System - Proteus 235 recall — FDA Z-2773-2020
Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten…
Class IIFDA: TerminatedIon Beam Applications S.A.
Medical DeviceAug 19, 2020
Smith & Nephew Tibial knee prosthesis recall — FDA Z-2774-2020
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Class IIFDA: OngoingSmith & Nephew, Inc.
Medical DeviceAug 19, 2020
Shanghai United Imaging Healthcare Co uMI 550 PET/CT Diagnostic Imaging System - Product recall — FDA Z-2800-2020
1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by…
Class IIFDA: TerminatedShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceAug 19, 2020
Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits recall — FDA Z-2803-2020
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceAug 19, 2020
Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T recall — FDA Z-2770-2020
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
Class IIFDA: TerminatedOrtho Clinical Diagnostics
Medical DeviceAug 19, 2020
Flower Orthopedics Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 recall — FDA Z-2786-2020
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceAug 19, 2020
HF Acquisition Co HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150 recall — FDA Z-2788-2020
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Class IIFDA: TerminatedHF Acquisition Co., LLC
Medical DeviceAug 19, 2020
Maquet Cardiovascular Us Sales Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal recall — FDA Z-2780-2020
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceAug 19, 2020
Flower Orthopedics Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product recall — FDA Z-2782-2020
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
Class IIFDA: TerminatedFlower Orthopedics Corporation
Medical DeviceAug 19, 2020
Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single recall — FDA Z-2801-2020
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceAug 19, 2020
Wright Medical Technology Hardware removal kit, Part Number 1985KIT1 - Product Usage: The recall — FDA Z-2796-2020
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Class IIFDA: TerminatedWright Medical Technology, Inc.
Medical DeviceAug 19, 2020
Arrow International NextStep Retrograde Replacement Hub Set - Product Usage: is indicated recall — FDA Z-2804-2020
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceAug 19, 2020
Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G recall — FDA Z-2771-2020
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
Class IIFDA: TerminatedOrtho Clinical Diagnostics
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.