August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical: 26
Severe: 242
High: 366
Moderate: 190
Low: 39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

Which agencies issued them

401–500 of 863

HighFDA (Devices)·Z-2680-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 301 rHead Stem Implant Plasma Coated, Size 4 units because literature reviews indicate higher revision rates than other similar devices.
Product
rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2670-2018·2018-08-15
Howmedica Radial Head Implant Recall Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 175 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1790-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella
Pepperidge Farm is recalling Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.
Product
Pepperidge Farm Goldfish Baked Snack Crackers Baked with Whole Grain Xtra Cheddar. Net Wt. 6.6 oz. (187g) bag, UPC 14100-04654
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2691-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 298 units of the rHead Recon Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2711-2018·2018-08-15
Howmedica Recalls 605 Bipolar Radial Head Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 605 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2687-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 396 rHead Recon Stem Implant Plasma Coated, Size 3 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2018·2018-08-15
New Era Orthopaedics Recalls Modera Pedicle Screw Shank Insertion Instrument
New Era Orthopaedics is recalling 6 shank insertion instruments for the Modera Modular Pedicle Screw System due to a laser weld failure reported after excessive force was applied.
Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2702-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher than other similar devices.
Product
Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1819-2018·2018-08-15
FUSIA Spicy Mongolian Noodle Bowl Recalled for Undeclared Peanuts
Marketing Concepts Group is recalling FUSIA Spicy Mongolian Noodle Bowls because the inner packaging contains undeclared peanuts.
Product
FUSIA Asian Inspirations Spicy Mongolian Noodle Bowl, NET WT 8.5 OZ (240g) Heat and Serve UPC# 041498135461 PRODUCT OF CHINA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2700-2018·2018-08-15
Howmedica Recalls 163 Orthopedic Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2732-2018·2018-08-15
Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 286 units of the rHead Radial Implant 6 mm Collar, Size 4, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1789-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella
Pepperidge Farm is recalling specific Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.
Product
Pepperidge Farm Goldfish Baked Snack Crackers Flavor Blasted Xtra Cheddar in the following sized containers: 1. Net Wt. 6.6 oz. (187g) bag, UPC 14100-08548; 2. Net Wt. 30 oz. (1.87 lbs) 850g) carton, UPC 14100-09658; 3. 9 Lunch Packs, Net Wt. 8.1 oz (230g)…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2728-2018·2018-08-15
Howmedica Recalls 180 Radial Stem Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 180 sterile-packed radial stem implants because literature reviews indicate a higher revision rate than other similar devices.
Product
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1767-2018·2018-08-15
Vitale Brothers Italian Bread Recalled for Undeclared Wheat
Vitale Brothers Bakery is recalling 134 loaves of Italian bread sold in Michigan due to undeclared wheat, a major allergen.
Product
Vitale Brothers Italian bread (1lb loaf) UPC1589410005
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2694-2018·2018-08-15
Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Revision Rates
Howmedica Osteonics Corp. is recalling 214 Radio Capitellum Small, Left orthopedic implants because literature reviews indicate higher revision rates than similar devices.
Product
Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1820-2018·2018-08-15
Brolite Products Recalls #7024 Chill Do 24 Dough Mix for Salmonella Risk
Brolite Products Inc is recalling 200 bags of #7024 Chill Do 24 dough mix in New Jersey due to potential Salmonella contamination.
Product
#7024 Chill Do 24 (whey, corn flour, l-cysteine, potassium bromate); Packaged in 50-lb paper bag.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2692-2018·2018-08-15
Howmedica rHead Recon Stem Implant Recalled for Performance Concerns
Howmedica Osteonics Corp. is recalling 216 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
Product
rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2682-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 268 units of the rHead Stem Implant 6mm Collar, Size 2, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2664-2018·2018-08-15
Stryker Radial Stem Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 396 Stryker rHead Radial Stem Implants, Size 2, because literature reviews indicate a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1764-2018·2018-08-15
Vitale Brothers Pumpernickel Bread Recalled for Undeclared Wheat
Vitale Brothers Bakery is recalling 20 loaves of Pumpernickel bread in Michigan due to undeclared wheat, a major allergen.
Product
Vitale Brothers Pumpernickel bread (1lb loaf) UPC1589410008
Category
Food
Distribution
1 state
HighFDA (Food)·F-1758-2018·2018-08-15
Aldi Recalls AnnaSea Poke Kits Due to Temperature Storage Issues
Aldi is voluntarily recalling AnnaSea Limu Ahi Poke Hawaiian Poke Kits because they were stored at temperatures above freezing, which can make them unsafe to eat.
Product
AnnaSea Limu Ahi Poke Hawaiian Poke Kits
Category
Food
Distribution
4 states
HighNHTSA·18V534000·2018-08-15
Forest River Recalls 2019 Prime Time Travel Trailers Due to Oven Defect
Forest River is recalling 2019 Prime Time Tracer and Avenger travel trailers because a missing oven diverter can cause the countertop to become extremely hot, increasing the risk of burn injuries.
Product
PRIME TIME — PRIME TIME, FOREST RIVER TRACER, AVENGER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2018·2018-08-15
Think Surgical Cutter Recall Due to Potential Head Detachment
Think Surgical is recalling 951 flat cutters used in total knee arthroplasty because the cutter head may detach from the shaft.
Product
Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2731-2018·2018-08-15
Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 431 radial stem implants because literature reviews indicate a higher revision rate than other similar devices.
Product
radial stem implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2723-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 1,213 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18V533000·2018-08-15
BMW Recalls 2019 430i and 440i Models for Air Bag Defect
BMW is recalling three 2019 430i and 440i vehicles because the front passenger air bag inflator may be defective, potentially affecting deployment in a crash.
Product
BMW — BMW 430I, 440I
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2706-2018·2018-08-15
Howmedica Recalls rHead Standard Extended Stem Orthopedic Implants
Howmedica Osteonics Corp. is recalling 36 units of rHead Standard Extended Stem implants due to a higher-than-expected revision rate and potential performance issues.
Product
rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2676-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 81 units of Stryker rHead Radial Head Implant Assemblies because literature indicates higher revision rates than similar devices.
Product
Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2665-2018·2018-08-15
Stryker Radial Stem Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 492 Stryker rHead Radial Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2710-2018·2018-08-15
Howmedica Recalls Radio Capitellum Broach Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 10 units of the Radio Capitellum Broach Large, Right, due to a higher-than-expected revision rate and potential performance issues.
Product
Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2677-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 270 rHead Stem Implant Plasma Coated, Size 1 units because literature indicates a higher revision rate than other similar devices.
Product
rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1765-2018·2018-08-15
Vitale Brothers Onion Rolls Recalled for Undeclared Wheat
Vitale Brothers Bakery is recalling 31 loaves of Onion Rolls sold in Michigan due to undeclared wheat.
Product
Vitale Brothers Onion Rolls 16 oz. (6 count per unit) UPC1589410013
Category
Food
Distribution
1 state
HighFDA (Food)·F-1762-2018·2018-08-15
Cracker Barrel Fudge Peanut Butter Candies Recalled for Peanut Mislabeling
Country Fresh Food & Confections Inc. is recalling Cracker Barrel Old Fashioned Country Candies Kettle Cooked Fudge Peanut Butter because the back panel label failed to declare peanut butter in the ingredients statement.
Product
Cracker Barrel OLD FASHIONED COUNTRY CANDIES KETTLE COOKED FUDGE PEANUT BUTTER, Nutrition Facts***INGREDIENTS: SUGAR, PEANUT BUTTER***PACKED ESPECIALLY FOR CRACKER BARREL OLD COUNTRY STORE, LEBANON, TENNESSEE 37067***
Category
Food
Distribution
1 state
HighFDA (Food)·F-1794-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella
Pepperidge Farm is recalling specific Goldfish cracker varieties because an ingredient supplier reported potential Salmonella in the whey powder used in their seasoning.
Product
Pepperidge Farm Goldfish Baked Snack Crackers, 45 Packs. Containing 17 Flavor Blasted Xtra Cheddar Packs, 17 Colors Packs, and 10 Pretzel. Net Wt. 44.9 oz. (2.8 lbs) (1.27kg) UPC 14100-04728.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2724-2018·2018-08-15
Howmedica Recalls Radial Head Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 628 sterile radial head implants because literature reviews indicate higher revision rates than other similar devices.
Product
radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1766-2018·2018-08-15
Vitale Brothers Pepperoni Rolls Recalled for Undeclared Wheat
Vitale Brothers Bakery is recalling 287 loaves of Pepperoni Rolls sold in Michigan because the packaging failed to list wheat as an ingredient.
Product
Vitale Brothers Pepperoni Roll 4.8 oz. (principal display panel incorrectly states .32 oz.) UPC1589410015
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2719-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 141 rHead Recon Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1769-2018·2018-08-15
JouJou's White Large Pita Bread Recalled for Undeclared Wheat
Constantine's International Foods is recalling JouJou's white large pita bread because the packaging failed to declare wheat as an ingredient.
Product
JouJou's white large pita bread
Category
Food
Distribution
5 states
HighFDA (Food)·F-1795-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella
Pepperidge Farm is recalling specific Goldfish cracker varieties due to potential Salmonella in a whey powder ingredient.
Product
Pepperidge Farm Goldfish Baked Snack Crackers, 30 Packs. Containing 8 Flavor Blasted Xplosive Pizza Packs, 14 Flavor Blasted Xtra Cheddar Packs, and 8 Grahams Vanilla Cupcake. Net Wt. 29.4 oz. (1.8 lbs) (833g) UPC 14100-04713.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2695-2018·2018-08-15
Howmedica Recalls 158 Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 158 Radio Capitellum Large, Right orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2673-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implant Due to Revision Rate
Howmedica Osteonics Corp. is recalling 285 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2662-2018·2018-08-15
Smiths Medical Recalls Medfusion Syringe Infusion Pumps with Defective Barrel Clamp Guides
Smiths Medical ASD Inc. is recalling 276 Medfusion Syringe Infusion Pumps because a ridge in the Barrel Clamp Guide may cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
Product
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2708-2018·2018-08-15
Howmedica Recalls rHead Recon Extended Stem Orthopedic Implants
Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem implants due to a higher-than-expected revision rate.
Product
rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1757-2018·2018-08-15
Aldi Recalls AnnaSea Wasabi Ahi Poke Kits Due to Temperature Issues
Aldi is voluntarily recalling AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits because they were stored at temperatures above freezing, which can make the food unsafe to eat.
Product
AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-2688-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 310 units of the rHead Recon Stem Implant, Size 4, because the revision rate is higher than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2739-2018·2018-08-15
VitalGo Total Lift Bed Recalled for Unintentional Support Surface Movement
Vitalgo Inc. is recalling 85 VitalGo Total Lift Beds in Texas due to a risk of the support surface moving unintentionally from a tilted to a horizontal position.
Product
VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2714-2018·2018-08-15
Howmedica Recalls 169 Stryker rHead Bipolar Stem Implants
Howmedica Osteonics Corp. is recalling 169 Stryker rHead Bipolar stem implants due to a higher-than-expected revision rate and potential performance issues.
Product
#1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2707-2018·2018-08-15
Howmedica Recalls rHead Recon Extended Stem Orthopedic Implants
Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem implants due to a higher-than-expected revision rate.
Product
rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2674-2018·2018-08-15
Stryker rHead Radial Head Implant Recall Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 150 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2720-2018·2018-08-15
Howmedica Recalls 387 Stryker rHead Bipolar Stem Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 387 units of the #4 Bipolar stem implant from the Stryker rHead system because literature reviews indicate a higher revision rate than other similar devices.
Product
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2697-2018·2018-08-15
Howmedica Recalls Radial Head Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates than other similar devices.
Product
Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2704-2018·2018-08-15
Howmedica Recalls rHead Standard Extended Stem Orthopedic Implants
Howmedica Osteonics Corp. is recalling 66 units of rHead Standard Extended Stem implants due to higher-than-expected revision rates.
Product
rHead Standard Extended Stem, 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2698-2018·2018-08-15
Howmedica Recalls Radial Head Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 166 Radial Head Assy Size #3 orthopedic implants because the revision rate is higher than other similar devices.
Product
Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2730-2018·2018-08-15
Howmedica Recalls rHead Radial Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 162 units of rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.
Product
rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18V535000·2018-08-15
Volvo Recalls 2019 XC40 Vehicles Due to Rear Seat Back Lock Issue
Volvo is recalling 2019 XC40 vehicles because rear seat back lock strikers may be missing. This defect could allow the seat back to move forward during hard braking or a crash, increasing injury risk.
Product
VOLVO — VOLVO XC40
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2709-2018·2018-08-15
Howmedica Recalls rHead Recon Extended Stem Orthopedic Implants
Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem Size 3 orthopedic implants due to a higher-than-expected revision rate.
Product
rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1796-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella
Pepperidge Farm is recalling specific Goldfish cracker cases due to potential Salmonella in whey powder used in seasoning.
Product
Pepperidge Farm Goldfish Baked Snack Crackers, 45 Packs. Containing 15 Flavor Blasted Xtra Cheddar Packs, 15 Colors Packs, 10 Pretzel Packs, and 5 Grahams Vanilla Cupcake. Net Wt. 46 oz. (2.9 lbs) (1.3kg) UPC 14100-04731.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2705-2018·2018-08-15
Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 45 rHead Standard Extended Stem implants because literature suggests a higher revision rate than other similar devices.
Product
rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2729-2018·2018-08-15
Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 750 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Product
radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18E083000·2018-08-15
Hickory Springs Recalls School Bus Seats Missing Warning Labels
Hickory Springs is recalling NextGen School Bus seats with Integrated Child Restraint Systems because they may be missing a warning label on the lower restraint strap.
Product
EQUIPMENT:OTHER:LABELS recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1792-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella Risk
Pepperidge Farm is recalling specific Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.
Product
Pepperidge Farm Goldfish Baked Snack Crackers Mix with Flavor Blasted Xtra Cheddar + Pretzel in the following sized containers: 1. Net Wt. 1.5 oz. (43g) UPC 14100-18633; 2. Net Wt. 6.6 oz. (187g) bag, UPC 14100-04917; 3. 11.5 oz. (326g) Re-sealable Bag, UPC…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2668-2018·2018-08-15
Howmedica Radial Head Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 190 units of Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2. The recall is due to higher revision rates identified in literature.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2617-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2608-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2606-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
Product
119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2631-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets because they are labeled as not containing DEHP, but may contain small amounts of the chemical.
Product
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2614-2018·2018-08-15
ICU Medical Recalls Lopez Valve Devices Due to DEHP Labeling Error
ICU Medical is recalling Lopez Valve, Sterile blood tubing accessories because some units were incorrectly labeled as not containing DEHP, though they may contain small amounts.
Product
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2654-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 126-inch Y-Type Blood Sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2638-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2616-2018·2018-08-15
ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling
ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1044-2018·2018-08-15
PharMEDium Recalls Ephedrine Sulfate Syringes Due to CGMP Deviations
PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.
Product
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2646-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling 160,016 units of blood tubing accessories because some were labeled as not containing DEHP, despite potentially containing small amounts.
Product
132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1049-2018·2018-08-15
Longbow Eyewash Solution Recalled for CGMP Deviations
Longbow First Aid Products Manufactory is voluntarily recalling 14,400 bottles of Eyewash Purified water 98.3% Ophthalmic Solution due to CGMP deviations.
Product
Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-2613-2018·2018-08-15
ICU Medical Lopez Valve Recall for Incorrect DEHP Labeling
ICU Medical is recalling Lopez Valves with Red Caps because they were labeled as DEHP-free but may contain small amounts of DEHP.
Product
Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2640-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they are labeled as not containing DEHP, even though they may contain small amounts of the chemical.
Product
112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1045-2018·2018-08-15
PharMEDium Recalls Rocuronium Bromide Syringes Due to CGMP Deviations
PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.
Product
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-2630-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2623-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers devices distributed in the US and several international countries.
Product
84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2607-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood set units because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2628-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as DEHP-free but may contain small amounts of the chemical.
Product
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2619-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2611-2018·2018-08-15
ICU Medical Blood Set Recall for Incorrect DEHP Labeling
ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.
Product
32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2610-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific blood set accessories because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2651-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.
Product
139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1036-2018·2018-08-15
Baxter Recalls Levofloxacin Injection Due to High Concentration Levels
Baxter Healthcare is recalling 711,216 bags of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.
Product
LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2656-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts of the chemical.
Product
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2637-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2612-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2629-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2653-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1034-2018·2018-08-15
Baxter Recalls Levofloxacin Injection Due to High Potency Levels
Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.
Product
LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2642-2018·2018-08-15
ICU Medical Recalls Blood Administration Sets Due to DEHP Labeling Error
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though they may contain small amounts of DEHP.
Product
100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2621-2018·2018-08-15
ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling
ICU Medical is recalling 160,016 Y-Type Blood Sets because some were labeled as not containing DEHP, though they may contain small amounts.
Product
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2632-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.
Product
100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2650-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2643-2018·2018-08-15
ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling
ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of the chemical.
Product
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2603-2018·2018-08-15
Medtronic CD HORIZON Spinal System Screws Recalled for Incorrect Laser Marking
Medtronic is recalling 47 CD HORIZON Spinal System screws because they are incorrectly laser marked as 5.5 mm diameter when they are actually 5.0 mm.
Product
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2618-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.
Product
88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1074-2018·2018-08-15
Teva Recalls Omega-3 Capsules Due to Unapproved Manufacturing Material
Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.
Product
Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1043-2018·2018-08-15
PharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations
PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.
Product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
Category
Drug
Distribution
0 states

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