August 2015 recalls

585 recalls were announced in August 2015.

What the numbers show

Critical: 75
Severe: 110
High: 158
Moderate: 224
Low: 18

Of the 585 recalls this month scored against our rubric, 13% are Critical, 19% are Severe.

Which agencies issued them

501–585 of 585

ModerateFDA (Drugs)·D-1281-2015·2015-08-05
Mutual Pharmaceutical Recalls Clonidine Hydrochloride Tablets Due to cGMP Deviations
Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets because the drug substance was dispensed in unauthorized rooms, violating cGMP standards.
Product
Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2309-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 178 G1 dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure than labeled.
Product
ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2313-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 686 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2236-2015·2015-08-05
EXP Recalls Unregistered Orthopedic Saw Blades Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling two sterile orthopedic saw blades because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2874-2015·2015-08-05
Dairy Farmers of America Recalls Pepper Jack Cheese Due to Plastic Film
Dairy Farmers of America is recalling Hyvee Pepper Jack cheese because plastic film may remain attached to the slices.
Product
Flavored Pasteurized Prepared Cheese Product: HYVEE 12/12OZ PEPPER JACK CHS PROD, 7545009334.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2278-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Broth with Vancomycin, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2290-2015·2015-08-05
Anspach Fluted Ball Dissection Tools Recalled for Labeling Inconsistency
The Anspach Effort, Inc. is recalling 353 Fluted Ball dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
Product
ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2297-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 95 G1 dissection tools because the labeled shaft exposure may not be consistent with all listed attachments, potentially resulting in greater exposure than specified.
Product
ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2252-2015·2015-08-05
EXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices
EXP Pharmaceutical Services Corp is recalling two units of tracheal stent sizing devices due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2312-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 78 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-2883-2015·2015-08-05
Dairy Farmers of America Recalls Borden Mozzarella Slices Due to Plastic Film
Dairy Farmers of America is recalling Borden 2% Light Mozzarella Reduced Fat Slices because a piece of plastic film strip might remain attached to the cheese.
Product
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/6.56OZ 2% LIGHT MOZZARELLA REDUCED FAT SLICES, 5300001605.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2244-2015·2015-08-05
EXP Pharmaceutical Services Recalls SECURESTRAP Absorbable Strap Fixation Devices
EXP Pharmaceutical Services Corp is recalling SECURESTRAP 5mm Absorbable Strap Fixation Devices because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2294-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 92 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.
Product
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2242-2015·2015-08-05
EXP Recalls PhysioMesh Surgical Mesh Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling two units of PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2878-2015·2015-08-05
Dairy Farmers of America Recalls White Cheddar Cheese Alternative Slices
Dairy Farmers of America is recalling SOYA KAAS White Cheddar Flavor Cheese Alternative slices because a piece of plastic film might remain attached to the cheese.
Product
White Cheddar Flavor Cheese Alternative: SOYA KAAS 12/8OZ WHITE CHEDDAR FLAVOR SLICES, 7801600478.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2215-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging
EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 devices because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2280-2015·2015-08-05
Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 65 Fluted Drum dissection tools because the specified shaft exposure may be inconsistent with attachments, potentially resulting in greater exposure.
Product
ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2273-2015·2015-08-05
Hardy Diagnostics Recalls MacConkey Agar and Other Media for Lack of Clearance
Hardy Diagnostics is recalling specific lots of MacConkey Agar and other diagnostic media because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2881-2015·2015-08-05
Dairy Farmers of America Recalls Cheese Products Due to Plastic Film Hazard
Dairy Farmers of America is recalling reduced-fat cheese products because a piece of plastic film strip might remain attached to the cheese slice.
Product
Reduced Fat Pasteurized Prepared Cheese Product: MEIJER 12/12OZ 2PCT AMER YLW,4125005136. ESSENTIAL EVERYDAY 12/10.7 OZ 2% AMER PROC YLW, 4130300844. BORDEN 12/6.56OZ 2% AMER YLW, 5300000605. BORDEN 12/10.67OZ 2% AMER SINGLES,2.99, 5300000693. HARRIS TEETER 12/12OZ 2%…
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2897-2015·2015-08-05
Dairy Farmers of America Recalls Imitation Process Cheese Food Due to Plastic Film
Dairy Farmers of America Inc. is recalling imitation pasteurized process cheese food products because a piece of plastic film strip might remain attached to the cheese slice.
Product
Imitation Pasteurized Process Cheese Food: VALUE TIME 12/8OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122509140. VALUE TIME 12/10.67OZ SANDWICH SLICES IMITATION PASTEURIZED PROCESS CHEESE FOOD, AMER IMIT YLW, 1122558045. VALUE TIME…
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2218-2015·2015-08-05
EXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices
EXP Pharmaceutical Services Corp is recalling Versaport Bladeless Trocar devices because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2311-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 80 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
Product
ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2277-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2272-2015·2015-08-05
Synthes Maxillary Plates Recalled for Incorrect Laser Etch Orientation
Synthes (USA) Products LLC is recalling 31 pre-bent maxillary plates due to potential incorrect laser etch denoting orientation.
Product
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2230-2015·2015-08-05
EXP Recalls Fiberwire Suture Scissors Due to Registration Violations
EXP Pharmaceutical Services Corp is recalling Fiberwire Suture Scissors because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2299-2015·2015-08-05
Anspach 7MM Fluted Acorn Dissection Tools Recalled for Labeling Inconsistency
The Anspach Effort, Inc. is recalling 189 Anspach 7MM Fluted Acorn dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.
Product
ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-2890-2015·2015-08-05
Dairy Farmers of America Recalls Borden Lactose Free American Cheese
Dairy Farmers of America is recalling Borden Lactose Free American Cheese because a piece of plastic film strip might remain attached to the cheese slice.
Product
Pasteurized Prepared Cheese Product: BORDEN 12/8OZ LACTOSE FREE AMER YLW, 5300000902.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2234-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders
EXP Pharmaceutical Services Corp is recalling 12mm vascular transcatheter septal occluders because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2287-2015·2015-08-05
Anspach Fluted Barrel Dissection Tools Recalled for Labeling Inconsistency
The Anspach Effort, Inc. is recalling 110 fluted barrel dissection tools because the labeled shaft exposure may be inconsistent with actual usage.
Product
ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2265-2015·2015-08-05
Ivoclar Vivadent Recalls IPS Empress Universal Glaze Spray Due to Coarse Particles
Ivoclar Vivadent is recalling IPS Empress Universal Glaze Spray because complaints indicated coarse particles in the glazed surface of dental restorations.
Product
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
Category
Medical Device
Distribution
4 states
ModerateFDA (Food)·F-2885-2015·2015-08-05
Dairy Farmers of America Recalls Shop Rite Non-Fat White Cheese
Dairy Farmers of America is recalling Shop Rite non-fat white cheese because plastic film strips may remain attached to the slices.
Product
SHOP RITE 12/12OZ AMER NON-FAT WHITE, 4119045823
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2219-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Implantable Staple Loading Units
EXP Pharmaceutical Services Corp is recalling three units of implantable staple loading units because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2889-2015·2015-08-05
Dairy Farmers of America Recalls Swiss Cheese Slices Due to Plastic Film
Dairy Farmers of America is recalling Borden Swiss Singles cheese slices because plastic film strips may remain attached to the cheese.
Product
Pasteurized Prepared Cheese Product: BORDEN 12/8OZ SWISS SINGLES CHEESE PROD WHT, 5300000682.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2263-2015·2015-08-05
McKesson Paragon Laboratory Management Software Recall for Data Display Errors
McKesson Technologies is recalling Paragon Laboratory Management software versions 12.1 and 12.1.1 because the Final Cumulative Report may display incorrect data when used with Microsoft SQL Server 2012.
Product
Paragon Laboratory Management
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2303-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 118 G1 dissection tools because the specified shaft exposure on the label may not be consistent with all listed attachments.
Product
ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2210-2015·2015-08-05
MTF Recalls Allograft Cortical Pins Due to Diameter Labeling Error
Musculoskeletal Transplant Foundation is recalling one lot of Allograft Cortical Pins because the 2.0 mm label may contain 2.4 mm pins.
Product
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Category
Medical Device
Distribution
7 states
ModerateFDA (Food)·F-2884-2015·2015-08-05
Dairy Farmers of America Recalls Reduced Fat Cheese Products Due to Plastic Film
Dairy Farmers of America is recalling reduced fat cheese products because a piece of plastic film might remain attached to the cheese slice.
Product
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2PCT AMER WHT, 5300001614.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2223-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Suction Devices
EXP Pharmaceutical Services Corp is recalling sterile suction devices because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2296-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 103 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-2879-2015·2015-08-05
Dairy Farmers of America Recalls Borden Sharp Cheddar Cheese Due to Plastic Film
Dairy Farmers of America is recalling Borden 2% Sharp Cheddar cheese because plastic film strips may remain attached to the slices.
Product
Reduced Fat Pasteurized Prepared Cheese Product: BORDEN 12/12OZ 2% SHARP CHEDDAR YELLOW, 5300000615.
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2905-2015·2015-08-05
Rachael's Gourmet Candy Necklaces Recalled for Undeclared Food Dyes
Consumer Product Distributors Inc. is recalling Rachael's Gourmet Candy Necklaces because they contain undeclared food dyes and mislabel one other.
Product
RACHAEL'S GOURMET Candy Necklaces, Net Wt. 1.95 oz.; UPC: 0-77449-50452-9
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-2239-2015·2015-08-05
EXP Recalls Unregistered Medical Device Exchange Round Diamond Bur
EXP Pharmaceutical Services Corp is recalling Round Diamond Bur Extra Coarse devices because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2873-2015·2015-08-05
Dairy Farmers of America Recalls Marvella American Cheese Due to Plastic Film
Dairy Farmers of America is recalling Marvella American Pasteurized Cheese Singles because a piece of plastic film might remain attached to the cheese slice.
Product
American Pasteurized Cheese Product: MARVELLA 12OZ 340G AMERICAN PASTEURIZED CHEESE, SINGLES, 5193319275.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2227-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems
EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems because the company failed to register as a medical device establishment or establish a quality system.
Product
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2880-2015·2015-08-05
Dairy Farmers of America Recalls American Cheddar Flavor Slices
Dairy Farmers of America is recalling American Cheddar Flavor Slices because a piece of plastic film might remain attached to the cheese.
Product
American Cheddar Flavor Slices: SOYA KAAS 12/8OZ AMERICAN CHEDDAR FLAVOR SLICES, 7801600480.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2248-2015·2015-08-05
EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging Operations
EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems due to failure to register as a medical device establishment and lack of a quality system.
Product
Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2306-2015·2015-08-05
Anspach Effort Recalls G1 Dissection Tools Due to Labeling Inconsistencies
The Anspach Effort, Inc. is recalling 796 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
Product
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-2886-2015·2015-08-05
Dairy Farmers of America Recalls American Cheese Products Due to Plastic Film
Dairy Farmers of America is recalling specific American cheese products because a piece of plastic film might remain attached to the cheese slice.
Product
Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ SINGLES AMERICAN CHEESE PRODUCT YLW, 3680047752. BORDEN BL 12/6OZ AMER CHS PROD YLW, 6317500640 BORDEN 24/4.37 OZ AMER CHS PROD YLW, 5300000330. BORDEN 24/6.56OZ AMER CHS PROD YLW, 5300000350. BORDEN 12/13.12OZ…
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2867-2015·2015-08-05
Atkins Recalls Chocolate Peanut Candies Due to Potential Mislabeling
Atkins Nutritionals is voluntarily recalling cases of Chocolate Peanut Candies because they may contain chocolate candies with peanut candy sachets.
Product
Atkins Chocolate Peanut Candies 5 ct. Case - UPC code 637480075770
Category
Food
Distribution
25 states
ModerateFDA (Devices)·Z-2282-2015·2015-08-05
Anspach Extra Coarse Diamond Drum Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 88 Extra Coarse Diamond Drums because the shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2214-2015·2015-08-05
EXP Recalls 5.5mm BioComposite Corkscrew Suture Anchor Due to Registration Failure
EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew Suture Anchors because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2222-2015·2015-08-05
EXP Pharmaceutical Services Recalls Mayfield Disposable Skull Pins
EXP Pharmaceutical Services Corp is recalling Mayfield Disposable Skull Pins because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2266-2015·2015-08-05
Philips Invivo Expression MRI Patient Monitoring System Labeling Recall
Philips is recalling 697 MRI patient monitoring systems because the labeling inaccurately lists endotracheal as a valid body temperature application site for the FlexTEMP sensor.
Product
Invivo Expression MRI Patient Monitoring System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2896-2015·2015-08-05
Dairy Farmers of America Recalls American Sliced Cheese Due to Plastic Film
Dairy Farmers of America is recalling Valu Time American Sliced Cheese because plastic film strips may remain attached to the cheese slices.
Product
American Pasteurized Cheese Product: VALU TIME 12/12OZ AMERICAN SLICES CHEESE PRODUCT YLW, 1122502996.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2285-2015·2015-08-05
Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 115 fluted drum dissection tools because the specified shaft exposure may be inconsistent with certain attachments, potentially resulting in greater exposure than labeled.
Product
ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2232-2015·2015-08-05
EXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles
EXP Pharmaceutical Services Corp is recalling two units of laparoscopic insufflation needles due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2212-2015·2015-08-05
EXP Pharmaceutical Services Recalls GelPort Laparoscopic Systems for Registration Violations
EXP Pharmaceutical Services Corp is recalling three GelPort Laparoscopic Systems because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2251-2015·2015-08-05
EXP Recalls Chocolate Balloon Catheters Due to Registration Deficiencies
EXP Pharmaceutical Services Corp is recalling one unit of a Chocolate Balloon Catheter because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2274-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance
Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2893-2015·2015-08-05
Dairy Farmers of America Recalls Cheese Products Due to Plastic Film Hazard
Dairy Farmers of America is recalling specific Food Club cheese products because a piece of plastic film might remain attached to the cheese slice.
Product
Pasteurized Prepared Cheese Product: FOOD CLUB 12/12 OZ CHEEZY DOES IT, PASTEURIZED PREPARED CHEESE PRODUCT, 3680032338.
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2902-2015·2015-08-05
Dairy Farmers of America Recalls Fat Free White American Cheese Slices
Dairy Farmers of America is recalling fat free white American cheese singles because plastic film strips may remain attached to the slices.
Product
Fat Free Pasteurized Prepared Cheese Product: ESSENTIAL EVERYDAY 12/10.7OZ SINGLES WHITE AMERICAN, FF IWS AMER PROC WHT, 4130300848. BORDEN 12/12OZ AMERICAN FAT FREE WHT, 5300001675.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2238-2015·2015-08-05
EXP recalls Stryker Round Fluted Burs due to registration violations
EXP Pharmaceutical Services Corp is recalling Stryker Round Fluted Burs because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2892-2015·2015-08-05
Dairy Farmers of America Recalls Borden American Cheddar Due to Plastic Film
Dairy Farmers of America is recalling Borden American Cheddar cheese because plastic film strips may remain attached to the slices.
Product
Pasteurized Prepared Cheese Product: BORDEN 12/13.12OZ DTT AMERICAN CHEDDAR PROD, 45110155767.3 .
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2895-2015·2015-08-05
Dairy Farmers of America Recalls Pepper Jack Cheese Due to Plastic Film
Dairy Farmers of America is recalling Coburn Farms Pepper Jack cheese singles because a piece of plastic film might remain attached to the cheese slice.
Product
Flavored Pasteurized Prepared Cheese Product: COBURN FARMS 12/12OZ SINGLES PEPPER JACK WHT,.5193315780.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2226-2015·2015-08-05
EXP Recalls Unregistered Implantable Clips Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling 17 units of implantable clips because the company failed to register as a medical device establishment or maintain a quality system.
Product
Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-2887-2015·2015-08-05
Dairy Farmers of America Recalls Cheese Products Due to Plastic Film Hazard
Dairy Farmers of America is recalling specific Borden and Cumberland cheese products because plastic film strips may remain attached to the slices.
Product
Pasteurized Prepared Cheese Product: BORDEN 12/12OZ WHITE AMER CHEESE PROD , 5300001636. CUMBERLAND 12/8OZ AMER CHEESE PROD WHITE, 4270401171
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-2229-2015·2015-08-05
EXP Recalls ETS FLEX 45 Endoscopic Articulating Linear Cutters
EXP Pharmaceutical Services Corp is recalling ETS FLEX 45 endoscopic cutters because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2247-2015·2015-08-05
EXP Recalls Unregistered Surgical Routers for Crani-A Procedures
EXP Pharmaceutical Services Corp is recalling four surgical routers because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2304-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 78 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.
Product
ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-2237-2015·2015-08-05
EXP Pharmaceutical Services Recalls Sterile Nonabsorbable Sutures and Sternotomy Wires
EXP Pharmaceutical Services Corp is recalling 19 units of sterile nonabsorbable sutures and sternotomy wires due to regulatory non-compliance regarding establishment registration and quality systems.
Product
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2254-2015·2015-08-05
Philips Brilliance CT 64-Channel Systems Recalled for Software Defects
Philips is recalling four Brilliance CT 64-channel systems due to software errors affecting image quality, dose control, and heart rate measurements.
Product
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2888-2015·2015-08-05
Dairy Farmers of America Recalls Borden Grilled Cheese Melts for Plastic Film
Dairy Farmers of America is recalling Borden Grilled Cheese Melts because a piece of plastic film might remain attached to the cheese slice.
Product
Pasteurized Prepared Cheese Product: .BORDEN 12/10.67OZ GRILLED CHEESE MELTS YLW PP2.99, 5300000429. BORDEN 12/12OZ GRILLED CHEESE MELTS YLW, 5300000436. BORDEN 48/12 OZ GRILLED CHEESE MELTS , 5300000436.
Category
Food
Distribution
39 states
ModerateFDA (Food)·F-2876-2015·2015-08-05
Dairy Farmers of America Recalls Fat-Free Cheese Products Due to Plastic Film
Dairy Farmers of America is recalling specific fat-free cheese products because a piece of plastic film strip might remain attached to the cheese slice.
Product
Non-Fat Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ AMER FAT FREE YELLOW, 3680045432. SHOPPRITE 12/12OZ AMER FAT FREE YLW, 4119045837. MEIJER 12/12 OZ AMERICAN FAT FREE COLOR, 4125056702. SCHNUCKS 12/12OZ AMER FAT FREE YLW, 4131858109.
Category
Food
Distribution
39 states
LowFDA (Devices)·Z-2322-2015·2015-08-05
Acon Recalls Mission Breath Alcohol Detector Kits for Labeling Amendment
Acon Laboratories is recalling 1,283 Mission Breath Alcohol Detector kits due to a labeling amendment. The devices are distributed nationwide.
Product
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2276-2015·2015-08-05
Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance
Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.
Product
Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2279-2015·2015-08-05
Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance
Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.
Product
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2240-2015·2015-08-05
EXP Recalls 6.0mm Round Fluted Bur Due to Registration Deficiencies
EXP Pharmaceutical Services Corp is recalling 5 units of 6.0mm Round Fluted Bur Soft Touch because the company failed to register as a medical device establishment or establish its own quality system.
Product
Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
Category
Medical Device
Distribution
6 states
SevereNHTSA·15V485000·2015-08-04
New Flyer Recalls NABI Transit Buses Due to Pressure Relief Defect
New Flyer is recalling specific 2014-2015 NABI transit buses because pressure relief devices may fail to vent gas, increasing the risk of tank explosion, fire, and injury.
Product
NABI — NABI 40LFW, 42BRT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·15E064000·2015-08-04
Emerson Pressure Relief Valves Recalled for Restricted Flow in Cargo Tank Trailers
Emerson is recalling specific Fisher Pressure Relief Valves used in cargo tank trailers. The valves may restrict flow during a fire, increasing the risk of tank explosion.
Product
FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:PRESSURE RELIEF DEVICES recall
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·15V486000·2015-08-04
Nissan Recalls Altima and Maxima for Fuel Leak Fire Risk
Nissan is recalling 46,846 Altima and Maxima vehicles because an improperly installed o-ring may cause fuel to leak during a crash, increasing fire risk.
Product
NISSAN — NISSAN ALTIMA, MAXIMA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·15V483000·2015-08-04
Volkswagen Recalls Vehicles Due to Air Bag Clock Spring Defect
Volkswagen is recalling specific 2010-2014 models because debris may damage the air bag clock spring, preventing the driver's air bag from deploying in a crash.
Product
VOLKSWAGEN — VOLKSWAGEN GTI, JETTA, PASSAT, GOLF
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·15205·2015-08-04
John Deere Recalls Riding Lawn Tractors Due to Brake Arm Failure
John Deere is recalling specific riding lawn tractors because a brake arm can fail, posing a crash hazard that could result in serious injury or death.
Product
John Deere lawn tractors
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·15V484000·2015-08-04
Forest River Recalls Cedar Creek Silver Back RVs for Weight Label Error
Forest River is recalling 2015-2016 Cedar Creek Silver Back recreational vehicles because the gross vehicle weight rating on the certification label is incorrect.
Product
CEDAR CREEK — CEDAR CREEK SILVER BACK
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·15206·2015-08-04
Manhattan Group Recalls Children's Elephant Activity Toys Due to Choking Hazard
Manhattan Group is recalling My Snuggly Ellie Activity Toys because the wooden ring can break into small pieces, posing a choking hazard to young children.
Product
My Snuggly Ellie Activity Toys
Category
Consumer Product
Distribution
Distributed nationwide
ModerateUSDA FSIS·107-2015·2015-08-03
Land O'Frost Recalls Beef Summer Sausage Due to Undeclared Pork
Land O'Frost is recalling 12 oz. packages of Ambassador Beef Summer Sausage because the product contains pork that is not declared on the label.
Product
Land O' Frost — Land O'Frost Recalls Sausage Product Due to Misbranding
Category
Food
Distribution
1 state

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