January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical: 161
Severe: 415
High: 291
Moderate: 533
Low: 23

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

Which agencies issued them

1401–1423 of 1423

ModerateFDA (Food)·F-1117-2014·2014-01-01
Lewis Bakeries Recalls Whole Wheat Bread Due to Metal Fragments
Lewis Bakeries is recalling 111,807 loaves of whole wheat bread nationwide because two small food-grade stainless steel fragments were found in two slices.
Product
Whole Wheat Bread packaged under the following names and sizes: UPC Name, size 41498-18997 L'Oven Fresh, Wheat Sandwich, 20 OZ 24126-01170 Healthy Life Soft Style, 100% Whole Wheat, 12 OZ 24126-33001 Roman Meal Sandwich, 24 OZ 24126-01134 Healthy Life Soft S
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0571-2014·2014-01-01
Data Innovations Instrument Manager Driver Software Recall for Sysmex UF-100
Data Innovations is recalling Instrument Manager driver software for the Sysmex UF-100 analyzer due to potential sample errors.
Product
Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0574-2014·2014-01-01
SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling 922 Indus Invue Screws because they are mismarked or unmarked. These screws are used to secure anterior cervical plates.
Product
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0569-2014·2014-01-01
Siemens IMMULITE Folic Acid Kits Recalled for Potential Expiration Issues
Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE Folic Acid kits due to a potential accelerated decline in counts that may cause failed adjustments before expiration.
Product
IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1142-2014·2014-01-01
Vega One Starter Kit Recalled for Chloramphenicol Contamination
Sequel Naturals is recalling nine lots of Vega One Starter Kit due to trace amounts of chloramphenicol.
Product
Vega One Starter Kit. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch. 7oz/197.2g containers.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0568-2014·2014-01-01
Ziehm Vision RFD C-Arm X-Ray System Recalled for Emergency Switch Change
Ziehm Imaging Inc is recalling 27 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Product
Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0579-2014·2014-01-01
OrthoPediatrics ACL Sleeve Installation Tool Recall for Incorrect Size Etching
OrthoPediatrics Corp is recalling 40 ACL Sleeve Installation Tools that may be etched with the wrong size. The tools were shipped in November 2013.
Product
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surger
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0573-2014·2014-01-01
SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling 993 Indus Invue screws used in cervical spine surgery because they are mismarked or unmarked.
Product
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0563-2014·2014-01-01
Ziehm Solo C-Arm X-Ray System Recalled for Emergency Switch Option
Ziehm Imaging Inc is recalling 58 Solo C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component rather than standard.
Product
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1146-2014·2014-01-01
Vega ONE Nutritional Shake Chocolate Recalled for Chloramphenicol Contamination
Sequel Naturals is recalling nine lots of Vega ONE Nutritional Shake Chocolate due to trace amounts of chloramphenicol.
Product
Vega ONE Nutritional Shake Chocolate. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch; sizes: 30.9oz/876 g, 41.7 g, and 438 g, containers.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0575-2014·2014-01-01
SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. These screws are used to secure anterior cervical plates.
Product
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0576-2014·2014-01-01
SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws
SpineFrontier, Inc. is recalling Indus Invue Screws due to mismarked and unmarked units. The recall covers nationwide distribution.
Product
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0558-2014·2014-01-01
Abbott Recalls HT Connect Peripheral Guide Wires Due to Coating Delamination
Abbott Vascular is recalling HT Connect Peripheral Guide Wires because a small number of devices show partial delamination of the PTFE coating.
Product
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1136-2014·2014-01-01
FoodState Recalls Enzyme Supplements Due to Chloramphenicol Contamination Risk
FoodState is recalling Innate Response Gluten and Dairy Ultra Shield Enzymes due to potential chloramphenicol contamination. Consumers should stop using the product and return it to the place of purchase.
Product
Innate Response Gluten and Dairy Ultra Shield Enzymes 60ct. (40127)
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-386-2014·2014-01-01
Airgas Recalls 145 Compressed Oxygen Cylinders Due to Short Fill Error
Airgas Medical Services is recalling 145 compressed oxygen cylinders that may be empty due to a manufacturing error. The cylinders were distributed to medical facilities in four states.
Product
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009
Category
Drug
Distribution
4 states
ModerateFDA (Devices)·Z-0553-2014·2014-01-01
SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect
SpineFrontier is recalling four PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.
Product
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0554-2014·2014-01-01
SpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect
SpineFrontier, Inc. is recalling 25 PedFuse Screw Inserters because they may not mate properly with the hex interface of the screws.
Product
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0567-2014·2014-01-01
Ziehm Vision R C-Arm X-Ray System Recalled for Emergency Switch Issue
Ziehm Imaging Inc is recalling 103 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray Systems because an engineering change made the emergency switch an optional component.
Product
Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1140-2014·2014-01-01
Vega Sport Protein Powder Recalled for Chloramphenicol Contamination
Sequel Naturals is recalling nine lots of Vega Sport Performance Protein Powder due to trace amounts of chloramphenicol.
Product
Vega Sport Performance Protein Dietary Supplement Chocolate Powder. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch. 29oz/822g, 1.3 oz/36g, 17x1.3oz/36g pouches.
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0560-2014·2014-01-01
Edwards Lifesciences Recalls Mislabelled Ergonic Double Acting DeBakey Forceps
Edwards Lifesciences is recalling three units of Ergonic Double Acting DeBakey Forceps due to incorrect laser etching that misidentified the instrument type.
Product
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-389-2014·2014-01-01
Hi-Tech Pharmacal Recalls Acyclovir Oral Suspension for Stability Failures
Hi-Tech Pharmacal is recalling Acyclovir Oral Suspension because the product's viscosity and pH levels fell below required specifications.
Product
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0531-2014·2014-01-01
C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies
C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.
Product
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical tr
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-382-2014·2014-01-01
Teva Recalls Qnasl Nasal Aerosol Due to Potential Clogged Stem Valves
Teva Pharmaceuticals USA is recalling Qnasl Nasal Aerosol units because some may have clogged stem valves, potentially affecting delivery.
Product
Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.
Category
Drug
Distribution
Distributed nationwide

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