Medical DeviceJun 13, 2018
Stryker 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box recall — FDA Z-2057-2018
Inadvertent shipment of expired units.
Class IIFDA: CompletedStryker 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 118
Records are ordered by the best available source date.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone recall — FDA Z-2086-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK IGE II recall — FDA Z-2097-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Orthofix Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only recall — FDA Z-2117-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone recall — FDA Z-2083-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia recall — FDA Z-2096-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK CA 19-9 recall — FDA Z-2069-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Fresenius Medical Care Renal Therapies Group NaturaLyte Liquid Acid Concentrate for recall — FDA Z-2110-2018
The bottles are mislabeled with an incorrect part number.
Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Prolactin recall — FDA Z-2087-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Orthofix L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2130-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Randox Laboratories RX Imola (RX4900) For Professional Use for the quantitative in vitro recall — FDA Z-2059-2018
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Class IIFDA: TerminatedRandox Laboratories
Medical DeviceJun 13, 2018
Orthofix Srl TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes recall — FDA Z-2063-2018
The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured…
Class IIFDA: TerminatedOrthofix Srl
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic recall — FDA Z-2094-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
GE Healthcare Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity recall — FDA Z-2101-2018
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJun 13, 2018
Orthofix Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r recall — FDA Z-2135-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
Medical DeviceJun 13, 2018
Tosoh Bioscience ST-AIA PACK Testosterone recall — FDA Z-2093-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJun 13, 2018
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor recall — FDA Z-2046-2018
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
Class IFDA: TerminatedDraeger Medical Systems, Inc.
Medical DeviceJun 13, 2018
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump recall — FDA Z-2113-2018
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a…
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJun 13, 2018
Orthofix Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only recall — FDA Z-2116-2018
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were…
Class IIFDA: TerminatedOrthofix, Inc.
FoodJun 13, 2018
Global Commodities WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH recall — FDA F-1565-2018
Product contains high levels of undeclared sulfites (2901 ppm).
Class IFDA: TerminatedGlobal Commodities Inc.
FoodJun 13, 2018
Heritage Short Bread pasteurized cream recall — FDA F-1540-2018
During a South Carolina State Department inspection the firm was notified that the label did not list wheat as an ingredient.
Class IIFDA: OngoingHeritage Short Bread, Inc.
FoodJun 13, 2018
The C.F. Sauer Company Blue Mountain Valley - Red Pepper Seasoning recall — FDA F-1531-2018
The C.F. Sauer Company has decided to initiate a recall of the following products: 1) Sauer - Red Pepper Seasoning (21 oz.) with the following lot codes: 18107R, 18031R, 17306R, 17219R,…
Class IIFDA: TerminatedThe C.F. Sauer Company
FoodJun 13, 2018
Trader Joe's Artisan Bread - Organic French Baguette recall — FDA F-1539-2018
FDA was notified by the Canadian Food Inspection Agency of that two lot codes of Trader Joe's Organic French Baguette may be contaminated with Listeria monocytogenes.
Class IIFDA: TerminatedTrader Joes Company
FoodJun 13, 2018
The C.F. Sauer Company Pocahontas - Red Pepper Seasoning recall — FDA F-1532-2018
The C.F. Sauer Company has decided to initiate a recall of the following products: 1) Sauer - Red Pepper Seasoning (21 oz.) with the following lot codes: 18107R, 18031R, 17306R, 17219R,…
Class IIFDA: TerminatedThe C.F. Sauer Company
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.