August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical: 26
Severe: 214
High: 393
Moderate: 191
Low: 39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

Which agencies issued them

401–500 of 863

HighFDA (Devices)·Z-2667-2018·2018-08-15
Howmedica Radial Head Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 170 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. 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-2713-2018·2018-08-15
Howmedica Recalls 546 Bipolar Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 546 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
#4 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-2679-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.
Product
rHead 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 (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-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 (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-2661-2018·2018-08-15
Arjohuntleigh Q-Connect Scale Recall Due to Spreader Bar Detachment Risk
Arjohuntleigh Magog is recalling Q-Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.
Product
Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.
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
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
HighFDA (Food)·F-1741-2018·2018-08-15
Whole Foods Bakery Products Recalled for Undeclared Soy Flour
Whole Foods Market is recalling various bakery products from Mid-Atlantic stores sold between May 25 and July 13 due to undeclared soy flour.
Product
CAKE BERRY CHANTILLY 6 IN, 41 Ounce
Category
Food
Distribution
0 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 (Food)·F-1737-2018·2018-08-15
Whole Foods Bakery Products Recalled for Undeclared Soy Flour
Whole Foods Market is recalling bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.
Product
CUPCAKE MANGO WHITE CHOCOLATE MEDIUM EA , 4.0 Ounce
Category
Food
Distribution
0 states
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-2726-2018·2018-08-15
Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 201 units of the rHead Radial Implant 6 mm Collar, Size 1, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead, Radial Implant 6 mm Collar, 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-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 (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 (Food)·F-1791-2018·2018-08-15
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 Flavor Blasted Slammin Sour Cream & Onion. Net Wt. 6.6 oz. (187g) bag, UPC 14100-09480.
Category
Food
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-1829-2018·2018-08-15
Seattle Sourdough Pub Buns Recalled for Undeclared Soy
Portland French Bakery L T D is recalling Seattle Sourdough Pub Buns because they may contain undeclared soy.
Product
Seattle Sourdough Pub Buns 6 pack, net wt. 16 oz., UPC 0-72220-10164-5
Category
Food
Distribution
8 states
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 (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-1763-2018·2018-08-15
Vitale Brothers Rye Bread Recalled for Undeclared Wheat
Vitale Brothers Bakery is recalling 21 loaves of Rye bread sold in Michigan due to undeclared wheat, posing a risk to individuals with wheat allergies.
Product
Vitale Brothers Rye bread (1lb loaf) UPC1589410007
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1075-2018·2018-08-15
Mylan Recalls Dymista Nasal Spray Due to Potential Glass Contamination
Mylan Pharmaceuticals is recalling 20,780 bottles of Dymista nasal spray because glass fragments may be present in the neck area of the bottles.
Product
DYMISTA — DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
Category
Drug
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
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-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-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-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-1736-2018·2018-08-15
Whole Foods Recalls Bakery Products for Undeclared Soy Flour
Whole Foods Market is recalling specific bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.
Product
CUPCAKE BERRY CHANTILLY MEDIUM, 4.5 Ounce
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2684-2018·2018-08-15
Howmedica Recalls rHead Stem Implant 6mm Collar Size 4
Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4, because the revision rate is higher than other similar devices.
Product
rHead 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-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-2735-2018·2018-08-15
Boston Scientific Guider Softip XF Guide Catheter Recalled for Polymer Degradation
Boston Scientific is recalling Guider Softip XF Guide Catheters due to potential polymer material degradation. The recall affects 31,005 units distributed in the US and Canada.
Product
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire
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 (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-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 (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 (Devices)·Z-2669-2018·2018-08-15
Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 230 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 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-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 (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-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 (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 (Food)·F-1759-2018·2018-08-15
Grizzlies Granolas Oregon Trail Mix Recalled for Undeclared Milk
Green Valley Group is recalling Grizzlies Granolas Oregon Trail Mix due to undeclared milk. The product was distributed in Idaho, Illinois, Oregon, and Washington.
Product
Grizzlies Brand and Grizzlies Granolas Oregon Trail Mix consisting of chocolate chips, fruit, seeds, and nuts. Product packaged in a cardboard box with a liner bag, net wt. 20 lbs., and was distributed to retailers for sale from their bulk bins. The product's ingredient
Category
Food
Distribution
4 states
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) Multi-pack
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1818-2018·2018-08-15
Flowers Foods Recalls Captain John Derst's Bread Due to Salmonella Risk
Flowers Foods is recalling Captain John Derst's Good Old Fashioned Bread due to potential salmonella contamination in a whey powder sub-ingredient.
Product
Captain John Derst's Good Old Fashioned Bread***NET WT 20 OZ (1 LB 4 OZ) 567 g***Nutrition Facts 22 servings per container*** Calories 80***INGREDIENTS:UPC 071316001180***INGREDIENTS: ENRICHED FLOUR, MALTED BARLEY, FLOUR, NIACIN, REDUCED IRON*** DISTRIBUTED BY FLOWERS BAKERIES,
Category
Food
Distribution
Distributed nationwide
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 (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-2659-2018·2018-08-15
Leica M530 OHX Microscope System Recalled for Power Module Design Weakness
Leica Microsystems is recalling 123 M530 OHX Microscope Systems due to a design weakness in the power insert module.
Product
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Category
Medical Device
Distribution
22 states
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
HighFDA (Devices)·Z-2672-2018·2018-08-15
Howmedica Recalls Radial Head Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head 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-2701-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 225 Radio Capitellum, Recon Head, Size #3 orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, 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-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-2693-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 170 Radio Capitellum Large, Left orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum Large, 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 (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-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 (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
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-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-2666-2018·2018-08-15
Stryker Radial Stem Implant Recalled Due to Higher Revision Rates
Howmedica Osteonics is recalling 280 Stryker rHead Radial Stem Implants because literature reviews show higher revision rates than similar devices.
Product
Lateral Assembly, Radial Stem 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-2683-2018·2018-08-15
Howmedica Recalls rHead Stem Implant 6mm Collar Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 305 units of the rHead Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead 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-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-2718-2018·2018-08-15
Howmedica Recalls Stryker rHead Radial Head Bipolar Stem Implants
Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.
Product
#3 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
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 adjunct
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-2648-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct
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-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-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 an
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2647-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to Mislabeling
ICU Medical is recalling 160,016 units of Y-Type Admin Sets because they were labeled as not containing DEHP, though they may contain small amounts.
Product
134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 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 tubin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2624-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
85" (216 cm) Y-Type Blood Set w/170 Micron Filter, 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 devices for needle-fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2634-2018·2018-08-15
ICU Medical Recalls Blood Administration Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free because they may contain small amounts of DEHP.
Product
164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, 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 (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 venipunctu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2644-2018·2018-08-15
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 they may contain small amounts of the chemical.
Product
99" (251 cm) 20 Drop Y-Type Blood Set w/200 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-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 adjunc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2622-2018·2018-08-15
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
84" Y-Type Blood Set w/170 Micron Filter, 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 devices for needle-free withdr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2625-2018·2018-08-15
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
99" (251 cm) 20 Drop Y-Type Blood Set w/200 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 (Food)·F-1756-2018·2018-08-15
Genestra AFA-gen Capsules Recalled for Excess Microcystins
Seroyal International is recalling Genestra AFA-gen capsules because microcystin levels exceeded the specified limit of 1 ppm.
Product
Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White 150cc HDPE Bottle with Desiccant and white cap, packed as 12 bottles / shipper case
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-2658-2018·2018-08-15
ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling specific blood tubing accessories labeled as DEHP-free because they may contain small amounts of DEHP.
Product
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, 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 se
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-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 b
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1042-2018·2018-08-15
Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Seal Defect
Morton Grove Pharmaceuticals is recalling 38,280 bottles of Prednisolone Sodium Phosphate Oral Solution because the tamper-evident foil seal is not completely intact.
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
Category
Drug
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 o
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-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 ven
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 as
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2655-2018·2018-08-15
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
107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, 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 set
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-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 venip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2627-2018·2018-08-15
ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, despite potentially containing small amounts.
Product
120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 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 venipuncture devices for
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2633-2018·2018-08-15
ICU Medical Recalls Bifuse Blood Sets Due to DEHP Labeling Error
ICU Medical is recalling 160,016 Bifuse Blood Sets because they are labeled as DEHP-free but may contain small amounts of DEHP.
Product
125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, 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 venipuncture
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 with
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2636-2018·2018-08-15
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
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, 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-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 wit
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 venipunctu
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 ven
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-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 venipunctu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2657-2018·2018-08-15
ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 116-inch Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
Product
116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, 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 device
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2609-2018·2018-08-15
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
168 cm (66") 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 withdrawal of b
Category
Medical Device
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 veni
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 withd
Category
Medical Device
Distribution
Distributed nationwide

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