Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga recall — FDA Z-3274-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
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 2018373 records · 3 categoriesJanuary 2018162 records · 2 categories
2018 recalls — page 50
Records are ordered by the best available source date.
Medical DeviceOct 3, 2018
Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The recall — FDA Z-3246-2018
The item is labeled as an 8.3mm, but it is actually a 12 mm.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceOct 3, 2018
Biomet UK HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole recall — FDA Z-3263-2018
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
Class IIFDA: TerminatedBiomet UK Ltd.
Medical DeviceOct 3, 2018
Medtronic Navigation Visualase Thermal Therapy System, Software: Visualase Software versions recall — FDA Z-3251-2018
Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the…
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga recall — FDA Z-3272-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Zimmer Biomet Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol recall — FDA Z-3252-2018
Expiration date incorrectly listed on the label
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceOct 3, 2018
Philips Electronics AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and recall — FDA Z-3228-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular recall — FDA Z-3238-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary recall — FDA Z-3243-2018
Screws on a Terumo Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceOct 3, 2018
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 recall — FDA Z-3253-2018
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are…
Class IIIFDA: TerminatedMedtronic Vascular
Medical DeviceOct 3, 2018
Boston Scientific ESSENTIO Pacemaker recall — FDA Z-3255-2018
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery…
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga recall — FDA Z-3276-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Zimmer Biomet Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment recall — FDA Z-3249-2018
The implant only has one bolt in the sterile package but it should have had two.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile recall — FDA Z-3271-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper F020 Biplane DR Table, System Code 722020 Vascular recall — FDA Z-3236-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular recall — FDA Z-3232-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga recall — FDA Z-3277-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga recall — FDA Z-3266-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga recall — FDA Z-3275-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Philips Electronics Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular recall — FDA Z-3239-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Medical DeviceOct 3, 2018
Intuitive Surgical da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply recall — FDA Z-3254-2018
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile recall — FDA Z-3265-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile recall — FDA Z-3268-2018
The back cap separates from the body of the vitrectomy cutter.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceOct 3, 2018
Philips Electronics Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular recall — FDA Z-3233-2018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
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.