DrugSep 12, 2018
Mckesson Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL recall — FDA D-1172-2018
Supterpotent Drug
Class IIFDA: TerminatedMckesson Corporation
Monthly breakdown
2018 recalls by month
Select a month to review the recall records reported during that period.
December 2018285 records · 4 categoriesNovember 2018342 records · 4 categoriesOctober 2018626 records · 4 categoriesSeptember 2018393 records · 4 categoriesAugust 2018569 records · 4 categoriesJuly 2018356 records · 4 categoriesJune 2018402 records · 4 categoriesMay 2018613 records · 4 categoriesApril 2018449 records · 3 categoriesMarch 2018523 records · 3 categoriesFebruary 2018612 records · 3 categoriesJanuary 2018290 records · 3 categories
2018 recalls — page 66
Records are ordered by the best available source date.
DrugSep 12, 2018
Akorn Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle recall — FDA D-1183-2018
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Class IIFDA: TerminatedAkorn, Inc.
Medical DeviceSep 5, 2018
Medical Components, Inc dba MedComp Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set recall — FDA Z-2934-2018
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken…
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceSep 5, 2018
Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES recall — FDA Z-2908-2018
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class IIFDA: TerminatedStryker Leibinger GmbH & Co. KG
Medical DeviceSep 5, 2018
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563 recall — FDA Z-2953-2018
The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
Class IIFDA: TerminatedSysmex America, Inc.
Medical DeviceSep 5, 2018
Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs recall — FDA Z-2951-2018
OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means…
Class IIFDA: TerminatedHaemonetics Corporation
Medical DeviceSep 5, 2018
Siemens Healthcare Diagnostics RAPIDPoint 405 Blood Gas Analyzer recall — FDA Z-2927-2018
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceSep 5, 2018
Mako Surgical Stryker Mako Vizadisc Hip Procedure Tracking Kit recall — FDA Z-2925-2018
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability…
Class IIFDA: TerminatedMako Surgical Corporation
Medical DeviceSep 5, 2018
Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF recall — FDA Z-2904-2018
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class IIFDA: TerminatedStryker Leibinger GmbH & Co. KG
Medical DeviceSep 5, 2018
Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING recall — FDA Z-2906-2018
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class IIFDA: TerminatedStryker Leibinger GmbH & Co. KG
Medical DeviceSep 5, 2018
Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING recall — FDA Z-2909-2018
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class IIFDA: TerminatedStryker Leibinger GmbH & Co. KG
Medical DeviceSep 5, 2018
GE Medical Systems China Co GE 9100c NXT anesthesia systems recall — FDA Z-2956-2018
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position.…
Class IIFDA: TerminatedGE Medical Systems China Co., Ltd.
Medical DeviceSep 5, 2018
Medical Components, Inc dba MedComp DUO FLOW CUSTOM TRAYS recall — FDA Z-2941-2018
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken…
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceSep 5, 2018
GE Medical Systems China Co GE Carestation 30 anesthesia systems recall — FDA Z-2955-2018
On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position.…
Class IIFDA: TerminatedGE Medical Systems China Co., Ltd.
Medical DeviceSep 5, 2018
CSL Behring GmbH N Latex CDT Kit recall — FDA Z-2931-2018
Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC…
Class IIFDA: TerminatedCSL Behring GmbH
Medical DeviceSep 5, 2018
Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 recall — FDA Z-2937-2018
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken…
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceSep 5, 2018
Mako Surgical Stryker Mako Vizadisc Knee Procedure Tracking Kit recall — FDA Z-2924-2018
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability…
Class IIFDA: TerminatedMako Surgical Corporation
Medical DeviceSep 5, 2018
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO recall — FDA Z-2946-2018
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceSep 5, 2018
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series recall — FDA Z-2926-2018
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
Class IIFDA: TerminatedStanbio Laboratory, LP
Medical DeviceSep 5, 2018
Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF recall — FDA Z-2898-2018
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Class IIFDA: TerminatedStryker Leibinger GmbH & Co. KG
Medical DeviceSep 5, 2018
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO recall — FDA Z-2947-2018
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Class IIFDA: TerminatedCivco Medical Instruments Co. Inc.
Medical DeviceSep 5, 2018
Medical Components, Inc dba MedComp DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT recall — FDA Z-2942-2018
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken…
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceSep 5, 2018
Medical Components, Inc dba MedComp Duo-Flow IJ Full Tray recall — FDA Z-2935-2018
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken…
Class IIFDA: TerminatedMedical Components, Inc dba MedComp
Medical DeviceSep 5, 2018
Siemens Healthcare Diagnostics RAPIDPoint 500 Blood Gas Analyzer recall — FDA Z-2928-2018
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
About the 2018 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.