DrugDec 18, 2019
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial recall — FDA D-0574-2020
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class IIFDA: TerminatedAuroMedics Pharma LLC
December 2019 recalls — page 8
These records include useful source details for the selected month.
DrugDec 18, 2019
Coast Quality Pharmacy, LLC dba Anazao Health Hydromorphone HCL and Baclofen and Clonidine recall — FDA D-0590-2020
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class IIFDA: TerminatedCoast Quality Pharmacy, LLC dba Anazao Health
VehicleDec 18, 2019
Ford bead recall — NHTSA campaign 19V903000
Ford Motor Company (Ford) is recalling certain 2020 F-150 trucks equipped with 17-inch spare tires. The spare tire could have been damaged when it was installed on the rim.
beadFord Motor Company
VehicleDec 12, 2019
Chrysler pressure monitoring and regulating systems recall — NHTSA campaign 19V887000
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 trucks. An incorrect Tire Pressure Monitoring System (TPMS) sensor could have been installed during production causing the sensor to…
pressure monitoring and regulating systemsChrysler (FCA US LLC)
VehicleDec 12, 2019
General Motors cables recall — NHTSA campaign 19V888000
General Motors LLC (GM) is recalling certain 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks. The battery positive (B+) cable rings may have been manufactured with excessive…
cablesGeneral Motors LLC
VehicleDec 12, 2019
General Motors abs warning light recall — NHTSA campaign 19V889000
General Motors LLC (GM) is recalling certain 2019 Chevrolet Silverado 1500, Cadillac CT6, and GMC Sierra 1500 vehicles. Due to an Electronic Brake Control Module (EBCM) software error, the…
abs warning lightGeneral Motors LLC
Medical DeviceDec 11, 2019
CooperSurgical Quantam 2000 Electrosurgical Generator, Part number 909075-05 recall — FDA Z-0601-2020
Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is…
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceDec 11, 2019
Zimmer Biomet Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic recall — FDA Z-0595-2020
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 11, 2019
Lens.com Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR recall — FDA Z-0609-2020
The product may be counterfeit and could have microbial issues.
Class IIFDA: CompletedLens.com
Medical DeviceDec 11, 2019
Steris Eagle 3000 Sterilizer, small steam sterilizer recall — FDA Z-0604-2020
Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Class IIFDA: TerminatedSteris Corporation
Medical DeviceDec 11, 2019
Philips HeartStart XL+ Defibrillator/Monitor, Model 861290 recall — FDA Z-0608-2020
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode,…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceDec 11, 2019
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm recall — FDA Z-0591-2020
One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.
Class IIFDA: TerminatedBrasseler USA I Lp
Medical DeviceDec 11, 2019
Allergan PLC XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 recall — FDA Z-0598-2020
Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the…
Class IIFDA: OngoingAllergan PLC
Medical DeviceDec 11, 2019
Theralase TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for recall — FDA Z-0607-2020
Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
Class IIIFDA: TerminatedTheralase Inc.
Medical DeviceDec 11, 2019
NDDd Medical Technologies EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function recall — FDA Z-0597-2020
The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower…
Class IIFDA: TerminatedNDDd Medical Technologies, Inc.
Medical DeviceDec 11, 2019
Zimmer Biomet Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual recall — FDA Z-0594-2020
Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 11, 2019
Miami Device Solutions, LLC Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product recall — FDA Z-0603-2020
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Class IIFDA: TerminatedMiami Device Solutions, LLC.
Medical DeviceDec 11, 2019
NDDd Medical Technologies EasyOne Pro Respiratory Analysis System Pulmonary Function Testing recall — FDA Z-0596-2020
The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower…
Class IIFDA: TerminatedNDDd Medical Technologies, Inc.
Medical DeviceDec 11, 2019
Steris Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam recall — FDA Z-0586-2020
The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car…
Class IIFDA: TerminatedSteris Corporation
Medical DeviceDec 11, 2019
Stryker Instruments Div. of Stryker Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch recall — FDA Z-0592-2020
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation
Medical DeviceDec 11, 2019
Stryker Instruments Div. of Stryker Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch recall — FDA Z-0593-2020
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation
Medical DeviceDec 11, 2019
Theralase TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee recall — FDA Z-0606-2020
Device was shipped without a Unique Device Identification (UDI) label.
Class IIIFDA: TerminatedTheralase Inc.
Medical DeviceDec 11, 2019
CooperSurgical Quantam 2000 Electrosurgical Generator, Part number 909075 recall — FDA Z-0600-2020
Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is…
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceDec 11, 2019
CooperSurgical Quantam 2000 Electrosurgical Generator, Part number 909075-05W recall — FDA Z-0602-2020
Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is…
Class IIFDA: TerminatedCooperSurgical, 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.