The Recall Desk

Archive

March 2014 recalls

554 recalls were announced in March 2014.

What the numbers show

Critical
40
Severe
147
High
238
Moderate
117
Low
12

Of the 554 recalls this month scored against our rubric, 7% are Critical, 27% are Severe.

1–100 of 554

  • SevereNHTSA·14V152000·2014-03-31

    GM Recalls 2014-2015 Trucks and SUVs for Transmission Oil Fire Risk

    General Motors is recalling specific 2014-2015 Chevrolet and GMC vehicles because a transmission oil cooler line may not be securely seated, creating a potential fire hazard.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, YUKON, TAHOE, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V153000·2014-03-31

    GM Recalls 1.4 Million Vehicles for Electric Power Steering Loss

    General Motors is recalling approximately 1.4 million vehicles due to a potential sudden loss of electric power steering assist, which increases the risk of a crash.

    Product
    SATURN — SATURN, CHEVROLET, PONTIAC ION, MALIBU MAXX, MALIBU, G6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V181000·2014-03-31

    Jaguar Recalls 2013-2014 XF Models Due to Loose Charge Air Cooler Hose Clamp

    Jaguar is recalling 2013-2014 XF 2.0L GTDi vehicles because a loose hose clamp may allow the Charge Air Cooler hose to detach, potentially causing the engine to stall and loss of steering and brake assistance.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V156000·2014-03-31

    Crossroads Recalls 2015 Trailers Due to Brittle Spring Hangers

    Crossroads RV is recalling 2015 Zinger, Rezerve, and Sunset Trail trailers because brittle frame spring hangers may fracture, increasing crash risk.

    Product
    CROSSROADS — CROSSROADS ZINGER, REZERVE, SUNSET TRAIL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V155000·2014-03-31

    Land Rover Recalls 2014 Range Rover Evoque for Rear Suspension Bolt Defect

    Land Rover is recalling 2014 Range Rover Evoque vehicles because damaged rear suspension bolts may fail, causing the link arm to separate and increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V151000·2014-03-31

    GM Recalls 2013-2014 Chevrolet Cruze for Right Front Half Shaft Fracture Risk

    General Motors is recalling 2013-2014 Chevrolet Cruze vehicles with 1.4L turbo engines because the right front half shaft may fracture, potentially causing loss of power or unexpected vehicle movement.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E011000·2014-03-31

    Speedway Motors Recalls Brake Light Switches Due to Fluid Leak Risk

    Speedway Motors is recalling specific brake light switches used in hot rods that may crack, causing brake fluid leaks and increased stopping distances.

    Product
    EXTERIOR LIGHTING:BRAKE LIGHTS:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V157000·2014-03-31

    Jaguar Recalls 2013-2014 XJ, XF, and XK for Rear Suspension Defect

    Jaguar is recalling 2013-2014 XJ, XF, and XK vehicles because rear toe links can separate, potentially causing loss of vehicle control and increasing crash risk.

    Product
    JAGUAR — JAGUAR XK, XF, XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V158000·2014-03-31

    Mercedes-Benz Recalls 2014 GL Models for Child Seat Anchor Defect

    Mercedes-Benz is recalling 2014 GL350, GL450, GL550, and GL63 vehicles because the second-row seat may not fold low enough for proper child seat anchoring.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GL550, GL450, GL350, GL63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V163000·2014-03-31

    Land Rover Recalls 2014 Range Rovers for Turn Signal Software Defect

    Jaguar Land Rover is recalling 5,238 2014 Range Rovers because a software defect may prevent the turn signal indicator from flashing at a double rate to warn of a malfunction.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V149000·2014-03-27

    Tiffany Coach Recalls 2009-2010 Buses Due to Electrical Fire Risk

    Tiffany Coach Builders is recalling 2009-2010 Coach, Limo, and Shuttle Buses because voltage spikes may damage electrical components, increasing the risk of a fire.

    Product
    TIFFANY — TIFFANY SHUTTLE BUS, COACH, LIMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1163-2014·2014-03-26

    Baxter Recalls Sodium Chloride IV Solutions Due to Particulate Matter

    Baxter Healthcare is voluntarily recalling 0.9% Sodium Chloride Injection IV solutions due to the presence of particulate matter, including fibers and plastic particles.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1212-2014·2014-03-26

    Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.

    Product
    FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1170-2014·2014-03-26

    Silver Sword capsules recalled for undeclared sildenafil ingredient

    Fabscout Entertainment is recalling Silver Sword capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.

    Product
    Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1158-2014·2014-03-26

    Baxter Recalls Clinimix E Bags Due to Particulate Matter

    Baxter Healthcare is recalling 14,574 bags of Clinimix E IV solution found to contain particulate matter, including wood, sodium citrate, and dextrose.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1677-2014·2014-03-26

    Starbucks Greek Yogurt Parfait Recalled for Undeclared Egg

    Gretchen's Shoebox Express is recalling Starbucks brand Greek Yogurt Raspberry & Lemon Parfait cups due to undeclared egg.

    Product
    Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a whit
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1169-2014·2014-03-26

    Clalis capsules recalled for undeclared sildenafil ingredient

    Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.

    Product
    Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1160-2014·2014-03-26

    Baxter Recalls Clinimix IV Bags Due to Particulate Matter

    Baxter Healthcare is recalling 7,388 bags of Clinimix 5/15 sulfite-free IV solution because they contain particulate matter, including wood, sodium citrate, and dextrose.

    Product
    CLINIMIX — CLINIMIX (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2014·2014-03-26

    Baxter Recalls 5% Dextrose Injection Due to Particulate Matter

    Baxter Healthcare is voluntarily recalling 105,216 containers of 5% Dextrose Injection due to the presence of particulate matter, including fibers and plastic particles.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2014·2014-03-26

    Baxter Recalls Clinimix E IV Bags Due to Particulate Matter

    Baxter Healthcare is recalling 7,068 bags of Clinimix E IV solution because they contain particulate matter, including wood, sodium citrate, and dextrose.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1679-2014·2014-03-26

    Tortillas Mexico Recalls Corn Tortillas Due to Metal Staple Contamination

    Tortillas Mexico is recalling corn tortillas with expiration dates from December 20, 2013, to February 27, 2014, after a consumer found a metal staple in a baked tortilla.

    Product
    CORN TORTILLAS: 18 CT YELLOW/WHITE 18 OZ USPC Code 1569603333, 36 COUNT YELLOW/WHITE 36 OZ USPC Code 1569603335/4, 75 COUNT WHITE CORN 5 LB,USPC Code 1569603331, 100 COUNT WHITE CORN 100 OZ USPC Code 1569603336, 36 COUNT MINI 24 OZ USPC Code 1569603332, 36 COUNT TAQUITO 23 OZ UPC
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1676-2014·2014-03-26

    All American Seasonings Recalls White Cheddar Jalapeno Seasoning Powder

    All American Seasonings is recalling specific lots of white cheddar jalapeno seasoning powder due to a potential salmonella contamination in the jalapeno powder ingredient.

    Product
    Item number T3695, White cheddar jalapeno seasoning powder, 50 lb bags.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1161-2014·2014-03-26

    Hospira Recalls Marcaine Injection Vials Due to Metal Particulate Matter

    Hospira is recalling 40,360 vials of Marcaine (bupivacaine hydrochloride) injection because some units contain visible metal particles that discolor the solution.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1673-2014·2014-03-26

    Purely Pomegranate Recalls Frozen Pomegranate Arils Due to Hepatitis A Concerns

    Purely Pomegranate, Inc. is voluntarily recalling frozen pomegranate arils due to public concerns about the Hepatitis A Virus.

    Product
    GOKNUR Organic Frozen/IQF Pomegranate Arils. Packed in 10 kg cases. Labeling is bilingual and in English, reads in part:"goknur***Product of Turkey***ORGANIC FROZEN/IQF POMEGRANATE ARILS***Production Date 17.10.2012***Lot No 12-15-13-2-1-O***Net Weight (kg) 10***Crop Year 2012
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1237-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.

    Product
    Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1222-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atri
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1232-2014·2014-03-26

    Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue

    Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.

    Product
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1678-2014·2014-03-26

    Tortillas Mexico Recalls Flour Tortillas Due to Metal Detector Malfunction

    Tortillas Mexico is recalling flour tortillas with expiration dates from December 20, 2013, to February 27, 2014, due to a metal detector malfunction that may have allowed metal fragments into the product.

    Product
    FLOUR TORTILLAS: FAJITA 6" 15 0Z UPC Code 1569602222, HOMESTYLE 8" 24 OZ UPC Code 1569602221, BURRITO 10" 28OZ UPC Code 1569602223, GRANDE 12" 36 OZ UPC Code 1569602224, JUAREZ 8" 24 OZ UPC Code 1569603337, 8" RESTAURANT 23 OZ UPC Code 1569602230, 10" RESTAURANT 28 OZ UPC Code 15
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1675-2014·2014-03-26

    Good Neighbors Specialty Foods Recalls Tabouli Salad Due to Foreign Object

    Good Neighbors Specialty Foods is recalling Tabouli Salad because a customer found a blade inside the product.

    Product
    Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068
    Category
    Food
    Distribution
    6 states
  • HighUSDA FSIS·pha-032614·2014-03-26

    USDA Issues Public Health Alert for Nutriom Egg Products Unfit for Consumption

    USDA FSIS issued a public health alert for Nutriom LLC egg products because the company refused to expand a recall of items found to be unfit for human consumption due to falsified lab results.

    Product
    FSIS Issues Public Health Alert For Egg Products Unfit For Human Consumption
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1680-2014·2014-03-26

    Tortillas Mexico Recalls Wheat Tortillas Due to Metal Staple Contamination

    Tortillas Mexico is recalling wheat tortillas because a consumer found a metal staple in a baked tortilla. The firm's metal detector was not functioning.

    Product
    WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1064-2014·2014-03-26

    Elekta Linear Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling SL & SLi Series linear accelerators because customers are resetting default values outside recommended factory settings.

    Product
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2014·2014-03-26

    Philips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 7 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2014·2014-03-26

    Otto Bock Recalls Aerial Wheelchair Cushions Due to Flammability Risk

    Otto Bock is recalling Aerial and Aerial Active wheelchair cushions because internal testing found a small risk of flammability after high-temperature washing.

    Product
    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 47
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1236-2014·2014-03-26

    Medline Sterile Foley Catheter Recalled for Blocked Lumen

    Convatec Inc. is recalling Medline Sterile Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two m
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1674-2014·2014-03-26

    High Mowing Organic Sprouting Seeds Recalled for Undeclared Wheat

    High Mowing Organic Seed is recalling 655 units of Organic Sprouting Seeds Ancient Eastern Blend because the product contains undeclared wheat.

    Product
    High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1225-2014·2014-03-26

    Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation

    Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.

    Product
    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS)
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1224-2014·2014-03-26

    Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass s
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1239-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 31,250 latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tu
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1215-2014·2014-03-26

    Biomet 3i Recalls BellaTek Zirconia Dental Abutments Due to Fracture Reports

    Biomet 3i is recalling BellaTek Zirconia Dental Abutments because of reports of fractures. The recall covers 10,454 units distributed worldwide.

    Product
    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1672-2014·2014-03-26

    Dayton Nut Specialties Recalls Bar Star Snack Mix for Allergen Mislabeling

    Dayton Nut Specialties Inc is recalling 59 cases of Bar Star Snack Mix because the packaging failed to declare direct allergens including peanuts, tree nuts, soy, and wheat.

    Product
    Bar Star Snack Mix; 25 lb. cardboard carton
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1240-2014·2014-03-26

    Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens construc
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1681-2014·2014-03-26

    CSM Bakery Recalls Chocolate Supreme Cake Layers Due to Foreign Material

    CSM Bakery Products North America is recalling specific lots of 10-inch Chocolate Supreme Cake Layers because they may contain pieces of a red plastic scoop.

    Product
    10" Chocolate Supreme Cake Layers, NET WT. 20 oz. packed in cases of 12. Keep Frozen until ready to use. CSM Bakery Products NA, Inc., Tucker, GA 30084 USA Product is for institutional use.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·14141·2014-03-26

    SATCO Recalls KolourOne LED Light Bulbs Due to Injury Risk

    SATCO Products is recalling KolourOne LED light bulbs because the metal housing can separate and fall, posing a risk of injury to bystanders.

    Product
    KolourOne Brand Panel Array 2.0 and DUO 2.0 PAR LED Light Bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V142000·2014-03-26

    Nissan Recalls 2013 Pathfinders for Transmission Hose Defect

    Nissan is recalling 2013 Pathfinders because a transmission hose may detach, causing fluid leaks and loss of acceleration.

    Product
    NISSAN — NISSAN PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2014·2014-03-26

    Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass s
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1216-2014·2014-03-26

    Siemens syngo Dynamics PACS Recalled for Potential Patient Data Mixup

    Siemens is recalling 50 syngo Dynamics PACS units because improper error handling could display images for one patient and reports for another, risking misdiagnosis.

    Product
    syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2014·2014-03-26

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System Recalled

    Mar Cor Purification is recalling 232 Millenium HX Portable Reverse Osmosis Systems due to high inlet water pressure and solenoid valve issues that could delay dialysis treatment.

    Product
    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2014·2014-03-26

    Exactech Recalls Gibralt Spine System Polyaxial Screws Due to Material Error

    Exactech is recalling 242 Gibralt Spine System Polyaxial Screws because they contain springs made of type-304 stainless steel instead of the specified titanium alloy.

    Product
    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiogra
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1263-2014·2014-03-26

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 5 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1238-2014·2014-03-26

    Convatec SLC Foley Catheters Recalled for Blocked Lumens

    Convatec Inc. is recalling 5,540 SLC 2-way Foley catheters because excess lubricious coating material was found blocking the lumen.

    Product
    SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens c
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1214-2014·2014-03-26

    Alere Triage TOX Drug Screen Recalled for False Negative PCP Results

    Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.

    Product
    Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Tri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2014·2014-03-26

    Teleflex Recalls Rusch Endobronchial Tubes Due to Cuff Seal Failure

    Teleflex Medical is recalling Rusch Brochopart endobronchial tubes because the cuff may inflate to one side, preventing a proper seal of the right lung.

    Product
    Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2014·2014-03-26

    Convatec Latex Foley Catheters Recalled Due to Blocked Lumen

    Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1245-2014·2014-03-26

    GE Healthcare Recalls CT Scanners Due to Head Scan Software Artifact

    GE Healthcare is recalling Optima CT580 and Discovery CT590RT scanners running software version 13BW16.3 because a software issue may cause artifacts that hide pathology during head scans.

    Product
    GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena ca
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1211-2014·2014-03-26

    Abbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors because they may produce inaccurate blood glucose readings when used with specific test strips.

    Product
    FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2014·2014-03-26

    Medical Information Technology Recalls MEDITECH Microbiology Software Due to Erroneous Results

    Medical Information Technology, Inc. is recalling MEDITECH Microbiology software releases 5.6 through 6.14 because of a potential for erroneous result reporting.

    Product
    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1164-2014·2014-03-26

    RX3 Pharmacy Recalls Hydroxyprogesterone Caproate Syringes Due to Crystallization

    RX South LLC is recalling 250 syringes of Hydroxyprogesterone Caproate 250mg/ml due to visible crystals formed by extreme cold during shipping.

    Product
    Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1168-2014·2014-03-26

    Perrigo Recalls Clindamycin Oral Solution Due to Particulate Matter

    Paddock Laboratories is recalling seven lots of Perrigo Clindamycin Palmitate Hydrochloride for Oral Solution due to the presence of particulate matter.

    Product
    Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1172-2014·2014-03-26

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because out-of-specification results indicate the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1265-2014·2014-03-26

    Clarity Medical Systems Recalls RetCam 3 Halogen Lamps for Premature Failure

    Clarity Medical Systems is recalling 234 RetCam 3 halogen lamps that may fail early, potentially damaging internal electrical components.

    Product
    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2014·2014-03-26

    Stryker Recalls 2.5MM Aggressive Sinuscopic Shaver Blades Due to Missing Scale

    Stryker is voluntarily recalling 90 units of 2.5MM Aggressive Sinuscopic Shaver Blades because the etched line guide is missing the required 1cm to 7cm number scale.

    Product
    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1219-2014·2014-03-26

    Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right at
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1244-2014·2014-03-26

    Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error

    Biomet, Inc. is recalling specific lots of Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.

    Product
    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1249-2014·2014-03-26

    Zimmer Recalls Natural-Knee N-K II Domed All-Poly Pat Components

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Pat components due to discoloration caused by premature oxidation.

    Product
    Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2014·2014-03-26

    Ortho-Clinical VITROS White Correction Factor Slides Recalled for Labeling Error

    Ortho-Clinical Diagnostics is recalling VITROS White Correction Factor Slides because an incorrect assay value was printed on the carton, which may delay reporting of specific test results.

    Product
    VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1251-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Prosthesis Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee II knee prostheses because a component was found to be discolored due to premature oxidation.

    Product
    Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Unicompartmental Knee System Components

    Zimmer, Inc. is recalling specific Natural-Knee II unicompartmental knee system tibia components due to discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1209-2014·2014-03-26

    AtriCure Recalls Reusable Clip Appliers Due to Cracked Spring

    AtriCure is recalling 46 Reusable Clip Appliers because a customer reported a cracked spring in the handle. The devices were distributed nationwide.

    Product
    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee II Posterior Stabilized Condylar Tibial Inserts because free radical oxidation caused discoloration.

    Product
    Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2014·2014-03-26

    Zimmer Recalls Natural-Knee/Apollo Knee Implants Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee/Apollo knee implants because a component was discolored due to premature oxidation.

    Product
    Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1261-2014·2014-03-26

    Zimmer Recalls Apollo Revision Knee System Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Revision/Constrained Knee System tibia inserts because they were discolored due to premature oxidation during storage.

    Product
    Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1260-2014·2014-03-26

    Zimmer Recalls Apollo Knee System Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Knee System tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

    Product
    Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2014·2014-03-26

    Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error

    Biomet is recalling 10 Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.

    Product
    Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1256-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Constrained Knee System Tibia Components

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee II Constrained Knee System tibia components due to discoloration caused by premature oxidation.

    Product
    Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1165-2014·2014-03-26

    Traxx Recalls Guaifenesin API Powder Due to Foreign Matter

    Traxx International Corp is recalling Guaifenesin API powder because it may contain polyethylene fibers from a sifting screen.

    Product
    Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2014·2014-03-26

    Zimmer Recalls Natural-Knee Flex System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.

    Product
    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2014·2014-03-26

    Zimmer Recalls Natural-Knee II System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee II System components due to discoloration caused by premature oxidation. The affected devices were stored in transparent containers exposed to light.

    Product
    Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2014·2014-03-26

    Zimmer Recalls Natural-Knee Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2014·2014-03-26

    Remel Recalls Oxoid Vancomycin Susceptibility Discs Due to Impregnation Defect

    Remel Inc is recalling Oxoid Vancomycin 30 mcg susceptibility discs because some may lack the antibiotic, potentially affecting in-vitro testing results.

    Product
    Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2014·2014-03-26

    Zimmer Recalls Natural-Knee II Poly Ultra Tibia Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee II Poly Ultra Tibia components worldwide due to discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1250-2014·2014-03-26

    Zimmer Recalls MOST Options Hinged Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of MOST Options System hinged tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

    Product
    MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1210-2014·2014-03-26

    DeRoyal Cotton Adjustable Limb Holders Recalled for Moldy Smell

    DeRoyal Industries is recalling 8,962 pairs of cotton adjustable limb holders due to a moldy smell. The products were distributed in the US and Argentina.

    Product
    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1259-2014·2014-03-26

    Zimmer Recalls Apollo Knee Tibial Baseplates Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Knee Tibial Baseplates and Inserts because free radical oxidation caused discoloration in some units.

    Product
    Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS S
    Category
    Medical Device
    Distribution
    Distributed nationwide

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