Medical DeviceFeb 7, 2018
Maquet Hemofiltration Standard Pack including BC 60 Plus-T 8036 recall — FDA Z-0490-2018
55 kits were distributed after their expiration date of September 2015.
Class IIFDA: TerminatedMaquet
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 210
Records are ordered by the best available source date.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM recall — FDA Z-0460-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM recall — FDA Z-0432-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM recall — FDA Z-0453-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM recall — FDA Z-0470-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM recall — FDA Z-0484-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
C.R. Bard BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The recall — FDA Z-0488-2018
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies…
Class IIFDA: TerminatedC.R. Bard, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM recall — FDA Z-0428-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM recall — FDA Z-0463-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number recall — FDA Z-0499-2018
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Class IIFDA: TerminatedRoche Diagnostics Corporation
Medical DeviceFeb 7, 2018
Beaver-Visitec International bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 recall — FDA Z-0501-2018
The protective shield was retracted, and the blade was exposed.
Class IIFDA: TerminatedBeaver-Visitec International Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM recall — FDA Z-0481-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM recall — FDA Z-0426-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM recall — FDA Z-0458-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM recall — FDA Z-0439-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM recall — FDA Z-0440-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM recall — FDA Z-0454-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM recall — FDA Z-0468-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM recall — FDA Z-0442-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM recall — FDA Z-0476-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Horiba Instruments, Inc dba Horiba Medical 10 ML REAGENT CUP, B1034626, SAP 1221034626 for recall — FDA Z-0493-2018
The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could…
Class IIFDA: TerminatedHoriba Instruments, Inc dba Horiba Medical
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM recall — FDA Z-0451-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceFeb 7, 2018
Ormco/Sybronendo Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers recall — FDA Z-0413-2018
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Class IIFDA: TerminatedOrmco/Sybronendo
Medical DeviceFeb 7, 2018
Zimmer Biomet Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM recall — FDA Z-0422-2018
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the…
Class IIFDA: TerminatedZimmer Biomet, 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.