Medical DeviceJan 17, 2018
ProSun International Sundream 12 V tanning bed recall — FDA Z-0319-2018
The 30 minute maximum tanning time has been reduced to 20 minutes.
Class IIFDA: TerminatedProSun International, LLC
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 222
Records are ordered by the best available source date.
Medical DeviceJan 17, 2018
Philips Healthcare IQon Spectral CT computed tomography x-ray system recall — FDA Z-0333-2018
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled,…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJan 17, 2018
Orthoscan Mobile Mini C-arm system Part # 1000-0001 recall — FDA Z-0258-2018
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom…
Class IIFDA: TerminatedOrthoscan, Inc.
Medical DeviceJan 17, 2018
Physio-Control LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e recall — FDA Z-0294-2018
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The…
Class IFDA: TerminatedPhysio-Control, Inc.
Medical DeviceJan 17, 2018
Encore Medical DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty recall — FDA Z-0326-2018
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Class IIFDA: TerminatedEncore Medical, Lp
Medical DeviceJan 17, 2018
Philips Healthcare Brilliance iCT SP computed tomography x-ray system recall — FDA Z-0332-2018
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled,…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJan 17, 2018
Edwards Lifesciences Certitude Delivery System and any associated Multipacks Models recall — FDA Z-0293-2018
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Class IFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceJan 17, 2018
Repro-Med Systems HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm recall — FDA Z-0318-2018
On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap…
Class IIFDA: TerminatedRepro-Med Systems, Inc.
Medical DeviceJan 17, 2018
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the recall — FDA Z-0324-2018
Potential for cracked luer hubs
Class IIFDA: TerminatedCordis Corporation
Medical DeviceJan 17, 2018
CareFusion 303 Alaris PCA Pump, Model 8120 recall — FDA Z-0323-2018
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Class IIFDA: TerminatedCareFusion 303, Inc.
Medical DeviceJan 17, 2018
Philips Healthcare Brilliance iCT computed tomography x-ray system recall — FDA Z-0331-2018
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled,…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceJan 17, 2018
Orthoscan Mobile Mini C-arm system Part # 1000-0004-FD recall — FDA Z-0261-2018
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom…
Class IIFDA: TerminatedOrthoscan, Inc.
Medical DeviceJan 17, 2018
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration recall — FDA Z-0320-2018
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined…
Class IIFDA: TerminatedBrainlab AG
Medical DeviceJan 17, 2018
Encore Medical EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE recall — FDA Z-0327-2018
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Class IIFDA: TerminatedEncore Medical, Lp
Medical DeviceJan 17, 2018
Orthoscan Mobile Mini C-arm system Part # 1000-0004 recall — FDA Z-0259-2018
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom…
Class IIFDA: TerminatedOrthoscan, Inc.
Medical DeviceJan 17, 2018
Repro-Med Systems Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400 recall — FDA Z-0317-2018
On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap…
Class IIFDA: TerminatedRepro-Med Systems, Inc.
FoodJan 17, 2018
Lovebiotics The Coconut Cult Mango Cream Probiotic Coconut Yogurt NET WT recall — FDA F-0655-2018
Products listed sodium caseinate in allergen statement; however it did not further identify the allergen of milk.
Class IIFDA: TerminatedLovebiotics, LLC
FoodJan 17, 2018
Harrisburg Dairies 365 brand Egg Nog, Grade A recall — FDA F-0562-2018
Dried Egg Yolks was not specifically stated in ingredient statement
Class IIFDA: TerminatedHarrisburg Dairies, Inc.
FoodJan 17, 2018
Jack Brown Produce Golden Del., Gala, Fuji, Honey Crisp recall — FDA F-0640-2018
Jack Brown Produce, Inc. initiated a voluntary recall of multiple varieties of apples following notification from the supplier that product may be contaminated with Listeria monocytogenes.
Class IFDA: TerminatedJack Brown Produce, Inc.
FoodJan 17, 2018
Coconuthead 5.3 oz and 12 oz recall — FDA F-0603-2018
Coconuthead LLC is recalling CO YO Coconut Yogurt Alternative CHOCOLATE due to container bloating.
Class IIFDA: TerminatedCoconuthead, LLC
FoodJan 17, 2018
Lovebiotics The Coconut Cult Coconut Cream Probiotic Coconut Yogurt NET WT recall — FDA F-0654-2018
Products listed sodium caseinate in allergen statement; however it did not further identify the allergen of milk.
Class IIFDA: TerminatedLovebiotics, LLC
FoodJan 17, 2018
Bush Brothers & Co BUSH'S BEST Original SEASONED WITH BACON & BROWN SUGAR BAKED recall — FDA F-0558-2018
Discovered swollen cans
Class IIFDA: TerminatedBush Brothers & Co
FoodJan 17, 2018
Spice Chain Paprika Hun Budapest 12/5oz, World Finer Foods recall — FDA F-0652-2018
Spice Chain Corporation has decided to initiate a product recall of Paprika after receiving several consumer complaints of finding beetles in retail containers.
Class IIFDA: TerminatedSpice Chain Corporation
FoodJan 17, 2018
Spice Chain Paprika HUN Kalosca 12/5o, World Finer Foods recall — FDA F-0653-2018
Spice Chain Corporation has decided to initiate a product recall of Paprika after receiving several consumer complaints of finding beetles in retail containers.
Class IIFDA: TerminatedSpice Chain 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.