DrugOct 9, 2019
KRS Global Biotechnology PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites) recall — FDA D-0087-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
October 2019 recalls — page 21
These records include useful source details for the selected month.
DrugOct 9, 2019
KRS Global Biotechnology LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) recall — FDA D-0067-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL recall — FDA D-0066-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) recall — FDA D-0101-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) recall — FDA D-0084-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV recall — FDA D-0118-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
KRS Global Biotechnology Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% recall — FDA D-0116-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
DrugOct 9, 2019
Colonia Care Pharmacy C-METHYLCOBALAMIN 25MG/ML INJECTION PFS recall — FDA D-0018-2020
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class IIFDA: TerminatedColonia Care Pharmacy
DrugOct 9, 2019
KRS Global Biotechnology Quadmix # 19 recall — FDA D-0092-2020
Lack of Assurance of Sterility
Class IIFDA: TerminatedKRS Global Biotechnology, Inc.
VehicleOct 9, 2019
Elantra lower ball joint recall — NHTSA campaign 19V721000
Hyundai Motor America (Hyundai) is recalling certain 2020 Elantra vehicles. The lower control arm ball joint fasteners may have been insufficiently tightened allowing the ball joint to…
lower ball jointHyundai Motor America
VehicleOct 9, 2019
Hyundai Motor lugs/nuts/bolts/studs recall — NHTSA campaign 19V720000
Hyundai Motor America (Hyundai) is recalling certain 2019 Ioniq Hybrid and 2020 Elantra vehicles. The right-side rear wheel lug nuts may have been insufficiently tightened, allowing the…
lugs/nuts/bolts/studsHyundai Motor America
VehicleOct 3, 2019
Chevrolet Equinox caliper recall — NHTSA campaign 19V704000
General Motors LLC (GM) is recalling certain 2020 Chevrolet Equinox vehicles. The rear brake calipers may have been produced with an incorrect lubricant, potentially causing the rubber…
caliperGeneral Motors LLC
Medical DeviceOct 2, 2019
GETINGE US SALES The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven recall — FDA Z-2559-2019
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the…
Class IIFDA: TerminatedGETINGE US SALES LLC
Medical DeviceOct 2, 2019
GN Otometrics Gold Cup Leadwire and Snap Leadwire with the following component descriptions recall — FDA Z-2553-2019
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
Class IIFDA: OngoingGN Otometrics
Medical DeviceOct 2, 2019
Sentinel CH SpA Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in recall — FDA Z-2552-2019
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT…
Class IIFDA: TerminatedSentinel CH SpA
Medical DeviceOct 2, 2019
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 recall — FDA Z-2549-2019
The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceOct 2, 2019
Philips Healthcare DigitalDiagnost C50, Stationary X-ray System recall — FDA Z-2498-2019
During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the…
Class IIFDA: TerminatedPhilips Healthcare
Medical DeviceOct 2, 2019
Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product recall — FDA Z-2556-2019
Products may contain the incorrect banner card within the kit
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceOct 2, 2019
Abbott Laboratories APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX recall — FDA Z-2755-2019
The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify:…
Class IIFDA: TerminatedAbbott Laboratories, Inc.
Medical DeviceOct 2, 2019
Elekta Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The recall — FDA Z-2560-2019
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Class IIFDA: OngoingElekta Inc.
Medical DeviceOct 2, 2019
MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical recall — FDA Z-2756-2019
The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.
Class IIFDA: OngoingMedline Industries Inc.
Medical DeviceOct 2, 2019
Vital Scientific N.V V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An recall — FDA Z-2558-2019
Instrument stopped working due to a software lockup, and no patient results are produced.
Class IIFDA: OngoingVital Scientific N.V.
Medical DeviceOct 2, 2019
Siemens Healthcare Diagnostics Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material recall — FDA Z-2754-2019
Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceOct 2, 2019
Smiths Medical ASD Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server recall — FDA Z-2554-2019
Customers who utilize PharmGuard Server Software (PGS) with Medfusion 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain…
Class IIFDA: TerminatedSmiths Medical ASD 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.