December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical: 72
Severe: 319
High: 264
Moderate: 310
Low: 63

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 31% are Severe.

Which agencies issued them

301–400 of 1028

ModerateFDA (Devices)·Z-0624-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0592-2015·2014-12-24
Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BIPOLAR FORCEPS, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0784-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of 3mm Bullet Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0695-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0783-2015·2014-12-24
Stryker Laparoscopic Grasper Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic blunt graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT GRASPER, 29CM, P/N 0250282056 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0727-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ENDO GRASPER, 33CM, P/N 0250080699 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0705-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG,5MM 45CM INSERT,PERFORATOR, P/N 0250080578S1 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0622-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0794-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0612-2015·2014-12-24
Stryker Endoscopy Recalls Metzenbaum Scissors Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080024. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0760-2015·2014-12-24
Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of 3mm Hook Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, HOOK SCISSORS, 20CM, P/N 0250282002 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0628-2015·2014-12-24
Stryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Allis Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, ALLIS FORCEPS, P/N 0250080240. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0673-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of atraumatic forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0732-2015·2014-12-24
Mexicantown Bakery Recalls Concha Chocolate Pastry for Undeclared Artificial Coloring
Mexicantown Bakery, Inc. is recalling Concha Chocolate pastries because they contain undeclared artificial coloring (FD&C Yellow #5 and #6).
Product
Concha Chocolate- pastry containing soy, eggs, wheat FD&C Yellow #5 and #6.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0426-2015·2014-12-24
GE Cabinet X-ray Systems Recalled for Performance Standards Non-Compliance
GE Inspection Technologies is recalling 11 cabinet X-ray systems that may fail to comply with performance standards.
Product
GE Cabinet X-ray systems
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0771-2015·2014-12-24
Stryker Endoscopy Recalls 3mm Biopsy Punch Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of 3mm Biopsy Punch instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0618-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0748-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0742-2015·2014-12-24
Beachbody Base Shake Recalled for Mislabeling as Fuel Shot
Beachbody is recalling specific lots of Hardcore Base Shake because some bottles were incorrectly labeled as Fuel Shot due to a labeling error at the contract manufacturer.
Product
Beachbody Hardcore Base Shake Lot #42932B22, #42931A22, and #42902B22 Black HDPE container with Black Lid. Label stated weight of 1 lb. 12.2 oz. (800 g.) Lot code information located on the bottom of the container in yellow ink.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0708-2015·2014-12-24
Stryker Endoscopy Recalls 5mm Insert Biopsy Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of 5mm Insert Biopsy Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT BIOPSY FORCEPS, SPOON W/PIN, 45CM, P/N 0250080581 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0806-2015·2014-12-24
American Medical Systems Recalls AdVance Male Sling Systems Due to Packaging Defects
American Medical Systems is recalling AdVance Male Sling Systems because sterile barrier packaging may fail during extreme shipping and handling.
Product
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0664-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Obturator Packages Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 11mm Obturator packages because the instructions for use do not support specific sterilization methods.
Product
PKG, OBTURATOR, 11MM, FOR HASSON CANNULA, P/N 0250080158. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0663-2015·2014-12-24
Stryker Endoscopy Recalls 11mm Trocars Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of 11mm trocars because the instructions for use do not support specific sterilization methods.
Product
PKG, TROCAR, 11MM, PYRAMIDAL TIP, P/N 0250080156. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0703-2015·2014-12-24
Stryker Endoscopy Recalls 5mm Metzenbaum Scissors Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 Mixter Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, MIXTER FORCEPS, P/N 0250080249. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0693-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled Due to Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0766-2015·2014-12-24
Stryker Laparoscopic Grasper Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM, P/N 0250282008 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0621-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0790-2015·2014-12-24
Stryker Dorsey Grasper Recall Due to Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 Dorsey Grasper instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0757-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0713-2015·2014-12-24
Tastefully Simple Recalls Cookies & Cream Fudge Due to Mold
Tastefully Simple is recalling specific lots of Cookies & Cream Fudge because mold is growing on the chocolate cookie pieces.
Product
Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of the recalled product, Cookies & Cream Fudge and 2 samples of a second product not being recalled. The product comes in small plastic container with lid (3.5" x 2.5" x 21.875"). A small spoon…
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0720-2015·2014-12-24
Stryker Endoscopy Recalls 5mm PEEK Monopolar Handles Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0599-2015·2014-12-24
Stryker Laparoscopic Knot Pushers Recalled for Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic knot pushers because the instructions for use do not support specific sterilization methods.
Product
PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0735-2015·2014-12-24
Stryker Endoscopy Recalls 5mm Right Angle Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm Right Angle Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0675-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0652-2015·2014-12-24
Stryker Maryland Forceps Recalled Due to Sterilization Parameter Errors
Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0737-2015·2014-12-24
Stryker Endoscopy Recalls Fenestrated Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 fenestrated forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0792-2015·2014-12-24
Stryker Endoscopy Recalls 180,573 Laparoscopic Graspers Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic atraumatic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0776-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, PERITONEAL SCISSORS, 29CM, P/N 0250282048 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0611-2015·2014-12-24
Stryker Endoscopy Recalls Fixable Cone for 11mm Hasson Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 units of the Fixable Cone for 11mm Hasson because the instructions for use do not support specific sterilization methods.
Product
PKG, FIXABLE CONE FOR 11MM HASSON, P/N 0250080180. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0631-2015·2014-12-24
Stryker Pennington Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 Pennington Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0798-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0633-2015·2014-12-24
Stryker Laparoscopic Claw Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic claw forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0773-2015·2014-12-24
Stryker Endoscopy Recalls 3mm PEEK Monopolar Handle Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of 3mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0616-2015·2014-12-24
Stryker Laparoscopic Reducers Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic reducers because the instructions for use do not support specific sterilization methods.
Product
PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0300-2015·2014-12-24
Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements
American Health Packaging is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.
Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0747-2015·2014-12-24
Stryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Allis Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0605-2015·2014-12-24
Stryker Laparoscopic Cannula Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic cannulas because the instructions for use do not support specific sterilization methods.
Product
PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0823-2015·2014-12-24
Biomet Sirius Cemented Hip Stem Recall Due to Packaging Mix-up
Biomet is recalling eight Sirius Polish Cemented Hip Stems because parts were mixed up prior to packaging and shipment.
Product
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0742-2015·2014-12-24
Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling specific Park Forceps instruments because the instructions for use do not support certain sterilization methods.
Product
PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0831-2015·2014-12-24
Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values
Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.
Product
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0820-2015·2014-12-24
Carestream DirectView CR Software Recalled for Reduced Mammographic Image Quality
Carestream Health is recalling 59 units of DirectView CR Software due to reduced image quality when printing true size multi-format images.
Product
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0606-2015·2014-12-24
Stryker Maryland Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0796-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0654-2015·2014-12-24
Stryker Endoscopy Recalls Tissue Grasper Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of tissue grasper forceps because the instructions for use do not support two specific sterilization methods.
Product
PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0600-2015·2014-12-24
Stryker Myoma Drill Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0740-2015·2014-12-24
Stryker Dorsey Grasper Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Dorsey Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0793-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions do not support specific sterilization methods.
Product
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0613-2015·2014-12-24
Stryker Metzenbaum Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0698-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0634-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0660-2015·2014-12-24
Stryker Myoma Drill Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0819-2015·2014-12-24
Trinity Biotech Captia Syphilis IgM Test Kit Recalled for Stability Failure
Clark Laboratories is recalling the Captia Syphilis IgM Capture Test Kit because it failed to meet its labeled expiry dating during routine stability monitoring.
Product
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of…
Category
Medical Device
Distribution
4 states
LowFDA (Drugs)·D-0302-2015·2014-12-24
Eisai Recalls Belviq Tablets Due to Missing or Illegible Labels
Eisai Inc. is recalling 121,680 bottles of Belviq (Lorcaserin HCl) 10 mg tablets because some bottles may lack labels or have illegible lot and expiry dates.
Product
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0662-2015·2014-12-24
Stryker Endoscopy Recalls 8mm Trocars Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 8mm trocars because the instructions for use do not support specific sterilization methods.
Product
PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0632-2015·2014-12-24
Stryker Endoscopy Recalls Claw Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Claw Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0672-2015·2014-12-24
Stryker Endoscopy Recalls ATRAUMATIC FORCEPS Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of ATRAUMATIC FORCEPS because the provided instructions do not support specific sterilization methods.
Product
PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0782-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0755-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support two specific sterilization methods.
Product
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0701-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0681-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0745-2015·2014-12-24
Stryker Laparoscopic Scissors Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling Metzenbaum curved scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0746-2015·2014-12-24
Stryker Kelly Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Kelly Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM, INSERT, KELLY FORCEPS, P/N 0250080753 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0732-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0609-2015·2014-12-24
Stryker Laparoscopic Hook Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0689-2015·2014-12-24
Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.
Product
PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0814-2015·2014-12-24
Aesculap Miethke Shunt System Recalled for Missing Patient Labels
Aesculap Inc. is recalling four units of the Miethke Shunt System miniNAV Valve due to missing patient labels. No patient injuries have been reported.
Product
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0697-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled for Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0826-2015·2014-12-24
Teleflex Recalls Weck Hemoclip Ligating Clips Due to Labeling Error
Teleflex Medical is recalling 3,180 units of Weck Hemoclip Ligating Clips because manufacturing and expiration dates were transposed on the packaging labels.
Product
WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0763-2015·2014-12-24
Stryker Laparoscopic Needle Nose Forceps Recalled for Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic needle nose forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 20CM, P/N 0250282005 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0739-2015·2014-12-24
Stryker Fundus Grasper Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Fundus Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS, P/N 0250080735 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0666-2015·2014-12-24
Stryker Endoscopy Recalls Palpation Probes Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 palpation probes because the instructions for use do not support specific sterilization methods.
Product
PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0804-2015·2014-12-24
AGFA Healthcare Recalls Radiomat M+ NIF Films Due to Coating Artifacts
AGFA Healthcare is recalling 142 units of Radiomat M+ NIF films because the coating may show small bright thin lines when processed.
Product
Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0304-2015·2014-12-24
Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed long-term stability testing for dissolution specifications.
Product
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA…
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·14V814000·2014-12-23
Caterpillar Recalls 2015 CT660 and CT681 Trucks for Brake Fire Risk
Caterpillar is recalling 57 model year 2015 CT660 and CT681 trucks because an improperly seated brake diaphragm may cause brake drag and a wheel end fire.
Product
CATERPILLAR — CATERPILLAR CT660, CT681
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V812000·2014-12-23
Spartan Recalls 2013-2015 Motorhomes Due to Steering Linkage Defect
Spartan Motors is recalling 277 model year 2013-2015 motorhomes and chassis cabs because steering linkage castle nuts may loosen, potentially causing a loss of steering control.
Product
SPARTAN — SPARTAN MM, METROSTAR, K2, GLADIATOR
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·15054·2014-12-23
Keurig Recalls MINI Plus Brewing Systems Due to Burn Hazard
Keurig is recalling MINI Plus Brewing Systems because water can overheat and spray out, causing burns. Consumers should contact Keurig for a free repair.
Product
Keurig® MINI Plus Brewing Systems
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·14V816000·2014-12-23
Porsche Recalls 2015 918 Models Due to Front Control Arm Fracture Risk
Porsche is recalling 39 model year 2015 918 vehicles because the front lower control arms may fracture, increasing the risk of a crash.
Product
PORSCHE — PORSCHE 918
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·14V813000·2014-12-23
Elgin Recalls 2014 Street Sweepers Due to Electrical Fire Risk
Elgin is recalling 2014 Eagle and Road Wizard street sweepers because battery and alternator wiring may conduct excessive current, increasing the risk of a fire.
Product
ELGIN — ELGIN ROAD WIZARD, EAGLE
Category
Vehicle
Distribution
Distributed nationwide
LowUSDA FSIS·088-2014·2014-12-23
DaBecca Sliced Uncured Apple Smoked Bacon Recalled for Misbranding
DaBecca is recalling approximately 3,450 pounds of sliced uncured apple smoked bacon because the labels lacked the USDA mark of inspection.
Product
DaBecca LLC — Recall Notification Report 088-2014 (DaBecca Sliced Uncured Apple Smoked Bacon)
Category
Food
Distribution
2 states
SevereNHTSA·14V811000·2014-12-22
Suzuki Recalls Kizashi and SX4 Models for Shift Selector Defect
Suzuki is recalling 2010-2013 Kizashi and SX4 vehicles because the shift selector can move out of Park without the brake pedal being depressed, increasing crash risk.
Product
SUZUKI — SUZUKI KIZASHI, SX4
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·087-2014·2014-12-22
BMG Trading Recalls Pork Leg Flank Produced Without Federal Inspection
BMG Trading is recalling approximately 26,108 pounds of pork leg flank products that were produced without the benefit of federal inspection.
Product
Canadian Firm Recalls Pork Products Produced Without Benefit of Inspection
Category
Food
Distribution
1 state
HighNHTSA·14V807000·2014-12-22
Navistar Recalls 2013-2015 International WorkStar Trucks for Headlight Wiring Defect
Navistar is recalling 2013-2015 International WorkStar trucks because reversed headlight wiring may reduce light output, increasing crash risk.
Product
INTERNATIONAL — INTERNATIONAL WORKSTAR
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·15714·2014-12-22
James Trading Group Recalls Croker Kids Fleece Hoodies Due to Strangulation Hazard
James Trading Group is recalling Croker Kids GAA Fleece Panel Hoodies because the neck drawstrings pose a strangulation hazard to children.
Product
Kids GAA Fleece Panel Hoodie
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·14E085000·2014-12-22
Roadhouse Recalls Voss 888CF Motorcycle Helmets for Shell Defect
Roadhouse Distribution is recalling Voss 888CF motorcycle helmets because the shell material failed penetration testing, increasing injury risk in crashes.
Product
EQUIPMENT:MOTORCYCLE:HELMETS recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·14E086000·2014-12-22
Shark Recalls Certain RAW Motorcycle Helmets for Impact Failure
Shark is recalling specific RAW motorcycle helmets that failed federal impact attenuation tests, increasing the risk of injury in a crash.
Product
EQUIPMENT:MOTORCYCLE:HELMETS recall
Category
Consumer Product
Distribution
Distributed nationwide
LowUSDA FSIS·086-2014·2014-12-22
Abe's Finest Meats Recalls Hickory Smoked Sliced Bacon for Misbranding
Abe's Finest Meats is recalling approximately 80,050 pounds of hickory smoked sliced bacon because the ingredient sodium nitrite is not declared on the label.
Product
Recall Notification Report 086-2014 (Hickory Smoked Sliced Bacon)
Category
Food
Distribution
2 states
SevereNHTSA·14E084000·2014-12-19
ZF Group Recalls 9-Speed Automatic Transmissions Due to Parking Pawl Defect
ZF Group is recalling 9-speed automatic transmissions where a contaminated parking pawl may dislodge, preventing the vehicle from locking in Park and increasing crash risk.
Product
POWER TRAIN:AUTOMATIC TRANSMISSION recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V803000·2014-12-19
Nissan Recalls 2015 Armada Vehicles for Transmission Parking Defect
Nissan is recalling 2015 Armada vehicles because a transmission defect may prevent the parking pawl from fully engaging, allowing the vehicle to move while in Park.
Product
NISSAN — NISSAN ARMADA
Category
Vehicle
Distribution
Distributed nationwide

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