The Recall Desk

Archive

April 2019 recalls

516 recalls were announced in April 2019.

What the numbers show

Critical
10
Severe
201
High
153
Moderate
131
Low
21

Of the 516 recalls this month scored against our rubric, 2% are Critical, 39% are Severe.

Which agencies issued them

401–500 of 516

  • LowFDA (Devices)·Z-1088-2019·2019-04-10

    Beaver Visitec Recalls Micro Knife 5.0mm Due to Misprinted Expiration Date

    Beaver Visitec is recalling 97 boxes of Micro Knife 5.0mm 30° instruments because the expiration date was misprinted as the lot number.

    Product
    Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1080-2019·2019-04-10

    McKesson Consult Diagnostic Fecal Occult Blood Test Recalled for Packaging Issues

    Cypress Medical Products LLC is recalling McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests because the packaging is too similar to other products, leading to a denial of CLIA waiver approval.

    Product
    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30
    Category
    Medical Device
    Distribution
    27 states
  • LowFDA (Drugs)·D-1067-2019·2019-04-10

    Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures

    Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected at the 24-month time point.

    Product
    CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V283000·2019-04-09

    Proterra Recalls 2015-2018 Catalyst Buses Due to Brake Fire Risk

    Proterra is recalling 2015-2018 Catalyst 40 buses because a clogged tow fitting cap can cause rear brakes to overheat and catch fire.

    Product
    PROTERRA — PROTERRA CATALYST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·044-2019·2019-04-09

    Great American Marketing Recalls Meat and Poultry Wraps for Listeria Risk

    Great American Marketing is recalling approximately 3,329 pounds of ready-to-eat meat and poultry wrap and salad products due to possible Listeria monocytogenes contamination.

    Product
    Great American Marketing Co. — Great American Marketing Co. Recalls Meat and Poultry Wrap and Salad Products Due to Possible Listeria Monocytogenes Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V282000·2019-04-09

    Peterbilt 520 Recall: Undersized Wires May Cause Engine Shutdown

    PACCAR is recalling 2017-2020 Peterbilt 520 trucks because undersized wires may overheat and melt, potentially causing an unexpected engine shutdown and increasing crash risk.

    Product
    PETERBILT — PETERBILT 520
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V281000·2019-04-09

    Horton Ambulances Recalled for Reversed Backup Camera Image

    Halcore Group is recalling 2016-2019 Horton ambulances because backup camera displays may revert to factory settings, causing the image to reverse and increasing crash risk.

    Product
    HORTON — HORTON TYPE I, TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V284000·2019-04-09

    Daimler Recalls 2019 Sprinter Vans for Headlight Sensor Calibration Issues

    Daimler Vans USA is recalling 2019 Freightliner and Mercedes-Benz Sprinter vans because the headlamp range adjustment sensor may not be calibrated, potentially affecting driver visibility.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V276000·2019-04-09

    AEV TraumaHawk Ambulances Recalled for Reversed Backup Camera Image

    Halcore Group is recalling 2016-2019 AEV TraumaHawk ambulances because backup camera displays may revert to factory settings, causing the image to reverse and increasing crash risk.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V280000·2019-04-09

    Pierce Frontline Vehicles Recalled for Brake Light Wiring Defect

    Pierce is recalling 2018-2019 Frontline C-35X, C-25, C-45X-3, and Encore Rescue vehicles because brake lights may illuminate without the pedal being pressed.

    Product
    FRONTLINE — FRONTLINE C-35X, C-25, ENCORE RESCUE, C-45X-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19102·2019-04-09

    Marpac Recalls GO Travel Sleep Sound Machines Due to Burn Hazard

    Marpac is recalling GO travel sleep sound machines because the internal battery can leak and cause an electrical short, posing a burn hazard.

    Product
    GO travel sleep sound machines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V279000·2019-04-08

    Load Trail Recalls 2018-2019 Dump Trailers Due to Bolt Failure Risk

    Load Trail is recalling 2018-2019 dump trailers because bolts on the hydraulic cylinder can break under heavy loads, causing the dump box to lower rapidly.

    Product
    LOAD TRAIL — LOAD TRAIL TANDEM AXLE DUMP, TRIPLE AXLE DUMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V278000·2019-04-08

    Ford Recalls F-Series Trucks Due to Block Heater Fire Risk

    Ford is recalling 2015-2019 F-150 and 2017-2019 Super Duty trucks because a damaged block heater cable could cause a fire.

    Product
    FORD — FORD F-150, F-550 SD, F-450 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·043-2019·2019-04-08

    JBS Plainwell Recalls Ground Beef Products Due to Possible Plastic Contamination

    JBS Plainwell is recalling approximately 43,292 pounds of ground beef products sold in Michigan and Wisconsin that may contain pieces of hard plastic.

    Product
    JBS Plainwell, Inc. — JBS Plainwell, Inc. Recalls Ground Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·19V274000·2019-04-05

    Nova Bus Recalls 2011-2019 LFS City Buses for Fire Risk

    Nova Bus is recalling 2011-2019 LFS city buses because an engine door fan electrical connector may overheat and cause a fire.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·042-2019·2019-04-05

    J&J Snack Foods Recalls Stuffed Sandwiches Due to Plastic Contamination

    J&J Snack Foods Handhelds Corp. is recalling Bremer hot stuffed sandwiches due to possible semi-transparent plastic contamination. No illnesses have been reported.

    Product
    J&J Snack Foods Handhelds Corp. — J&J Snack Foods Handhelds Corp. Recalls Stuffed Sandwich Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V275000·2019-04-05

    Kenworth T680 and T880 Recalled for Parking Brake Signal Delay

    PACCAR is recalling 2018-2020 Kenworth T680 and T880 trucks because a parking brake signal delay in cold weather may cause unexpected vehicle movement.

    Product
    KENWORTH — KENWORTH T680, T880
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V273000·2019-04-04

    BMW Recalls 2006 Models Due to PCV Valve Fire Risk

    BMW is recalling 2006 3, 5, and Z4 series vehicles because a heater in the PCV valve may short circuit, increasing the risk of a fire.

    Product
    BMW — BMW Z4, 530XI, 525I, 325XI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·041-2019·2019-04-04

    Blount Fine Foods Recalls Chicken Soup for Undeclared Milk Allergen

    Blount Fine Foods is recalling frozen chicken soup products due to misbranding and an undeclared milk allergen. No adverse reactions have been reported.

    Product
    Blount Fine Foods — Blount Fine Foods Recalls Ready-To-Eat Chicken Soup Product due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·19099·2019-04-04

    Vivitar Recalls Hot/Cold Massage Balls Due to Burn Hazard

    Vivitar is recalling hot/cold massage balls sold at Target because they can leak or rupture during microwaving, posing a burn hazard.

    Product
    Hot/cold massage balls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1085-2019·2019-04-03

    Blue Fusion Capsules Recalled for Undeclared Prescription Ingredients

    Ata International Inc is recalling Blue Fusion Capsules because FDA analysis found undeclared prescription ingredients, including Sildenafil and Tadalafil.

    Product
    Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1286-2019·2019-04-03

    O Organics Organic Whole Strawberries Recalled for Norovirus

    Nature's Touch Frozen Foods is recalling O Organics Organic Whole Strawberries after FDA testing found Norovirus in frozen strawberries from Turkey.

    Product
    O Organics Organic Whole Strawberries; NET WT. 48 oz. (3 lb.) 1.36 kg UPC: 079893402758 Distributed by: Lucerne Foods, Pleasanton, CA 94566
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1282-2019·2019-04-03

    Surtidoras Bakery Marble Muffin Recalled for Undeclared Milk Allergen

    Surtidoras Bakery is recalling 21 packages of Marble Muffins because the ingredients list includes whey but fails to declare milk as an allergen.

    Product
    Marble Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR *** SOYBEAN OIL***EGGS***SOY LECITHIN ***WHEY***SOYBEAN OIL AND WHOLE EGGS***".…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1042-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1072-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·F-1203-2019·2019-04-03

    Bauer's Candies Recalls QVC Christmas Bags Due to Hepatitis A Risk

    Bauer's Candies is recalling QVC 3/8 oz Christmas bags due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    QVC 3/8 oz bags for Christmas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1070-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk

    ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·F-1206-2019·2019-04-03

    Bauer's Candies Recalls 8 oz Modjeskas Due to Hepatitis A Risk

    Bauer's Candies is recalling 8 oz assorted modjeskas and chocolate modjeskas due to a risk of Hepatitis A exposure. The products were distributed to retail locations in Kentucky and Illinois and to private individuals in 27 states and Iceland.

    Product
    8 oz assorted modjeska/chocolate modjeskas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1185-2019·2019-04-03

    Utz Recalls Bachman Pretzels Due to Undeclared Milk Allergen

    Utz Quality Food is recalling Bachman Original Twist Pretzels because butter pretzels were mistakenly packaged in regular pretzel bags, creating an undeclared milk allergen hazard.

    Product
    Bachman Original Twist Pretzels,10 oz.Bag (flexible film) UPC: 0-77817-10580-8
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0986-2019·2019-04-03

    Maquet Cardiohelp Emergency Drive Recalled for Gearwheel Assembly Defect

    Maquet Cardiovascular is recalling 10 units of the Cardiohelp Emergency Drive because the gearwheel may have been incorrectly reassembled, leading to inadequate operation.

    Product
    Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1204-2019·2019-04-03

    Bauer's Candies Recalls Salted Combo Modjeskas Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling 1 lb salted combo modjeskas due to a risk of Hepatitis A exposure. The product was distributed to retail locations in Kentucky and Illinois, and to private individuals in multiple states and Iceland.

    Product
    1 lb salted combo modjeskas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1191-2019·2019-04-03

    Fullei Fresh Organic Mung Bean Sprouts Recalled for Listeria Risk

    Kwokcheng Enterprise is recalling Fullei Fresh Organic Mung Bean Sprouts due to potential Listeria monocytogenes contamination. The product was distributed to Whole Foods in Florida and Freedom Fresh in Miami.

    Product
    Fullei Fresh brand Organic Mung Bean Sprouts in a 4 oz. clear plastic clamshell container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1192-2019·2019-04-03

    Soom Chocolate Tahini Halva Spread Recalled for Salmonella Risk

    Soom Foods is recalling 1oz Chocolate Sweet Tahini Halva Spread squeeze packs because Salmonella was found in a sample by the contracted manufacturer.

    Product
    Soom Chocolate Sweet Tahini Halva Spread 30 ml ( 1oz )Squeeze Pack
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1044-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-1202-2019·2019-04-03

    Bauer's Candies Recalls Salted Combo Modjeskas Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling 1 lb salted combo modjeskas due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    1 lb salted combo modjeskas
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1195-2019·2019-04-03

    Bauer's Candies Recalls Sea Salt Modjeskas Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling Sea Salt Modjeskas due to a risk of Hepatitis A exposure. The candy was distributed to retail locations and private individuals in multiple states.

    Product
    Sea Salt Bauer's Candies Modjeskas NET WT 8 oz bag, bulk, 4 oz bag, 1 lb, 2 lb, 8 oz box
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1201-2019·2019-04-03

    Bauer's Candies Recalls Candy Combos Due to Hepatitis A Exposure Risk

    Bauer's Candies, Inc. is recalling various candy combos due to a risk of Hepatitis A exposure. The products were distributed to retail locations and private individuals in multiple states.

    Product
    1 lb QVC combo, 1 lb combo, 2 lb combo, 12 oz combo, 8 oz combo, holiday combo
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1199-2019·2019-04-03

    Bauer's Candies Recalls Bulk Chocolate Caramels Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling bulk chocolate caramels due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    bulk chocolate caramels
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1284-2019·2019-04-03

    Surtidoras Bakery Recalls Blueberry Muffins Due to Undeclared Milk Allergen

    Surtidoras Bakery Inc is recalling 44 packages of Blueberry Muffins distributed in Washington because the product contains milk but does not list it on the label.

    Product
    Blueberry Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR *** SOYBEAN OIL***WHEY***WHEAT GLUTEN***EGGS*** SOY FLOUR***SOYBEAN OIL AND…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1194-2019·2019-04-03

    Bauer's Chocolate Modjeskas Recalled for Hepatitis A Exposure Risk

    Bauer's Candies is recalling Chocolate Modjeskas due to a risk of Hepatitis A exposure. The products were distributed to retail locations and private individuals in multiple states.

    Product
    Bauer's Candies Chocolate Modjeskas NET WT 4 oz & 8 oz bags, 8 oz box, bulk, & 1 lb box
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Food)·F-1283-2019·2019-04-03

    Surtidoras Bakery Recalls Banana Muffins for Undeclared Milk Allergen

    Surtidoras Bakery is recalling 104 packages of Banana Muffins sold in Washington because the ingredients and contains statements fail to declare milk, a major allergen.

    Product
    Banana Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR *** SOYBEAN OIL***WHEY***WHEAT GLUTEN***EGGS*** SOY FLOUR***SOYBEAN OIL AND WHOLE…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1198-2019·2019-04-03

    Bauer's Candies Recalls Bulk Assorted Candy Due to Hepatitis A Risk

    Bauer's Candies, Inc. is recalling 2 cases of bulk assorted candy due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    Bulk assorted
    Category
    Food
    Distribution
    26 states
  • SevereFDA (Devices)·Z-1053-2019·2019-04-03

    Philips UroDiagnost MRF Recall Due to Missing Locking Plate

    Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1197-2019·2019-04-03

    Bauer's Candies Caramels Recalled for Hepatitis A Exposure Risk

    Bauer's Candies, Inc. is recalling specific caramel products due to a risk of Hepatitis A exposure. The affected items were distributed to retail locations and private individuals in multiple states.

    Product
    Bauer's Candies Caramels NET WT 4 oz (bag) & bulk, QVC 4 pack caramels
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-1193-2019·2019-04-03

    Bauer's Candies Recalled for Potential Hepatitis A Exposure Risk

    Bauer's Candies is recalling Modjeskas candies due to a risk of Hepatitis A exposure. The products were distributed to retail locations and private individuals in multiple states.

    Product
    Modjeskas Bauer's Candies NET WT 8 oz, 12 oz, 16 oz, 32 oz. boxes & 4 oz, 8 oz bags, 400 pc case, 216 pc case
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-1054-2019·2019-04-03

    Philips OmniDiagnost X-ray System Recalled for Missing Locking Plate

    Philips North America is recalling 1,696 OmniDiagnost Classic X-ray systems because a missing locking plate may cause unexpected stand or table movement that users cannot stop.

    Product
    Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1187-2019·2019-04-03

    Jacques Big Daddy Dark Chocolate Bar Recalled for Undeclared Milk

    Jacques Torres Manufacturing is recalling Big Daddy Dark Chocolate Bars because they contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Jacques Big Daddy Dark Chocolate Bar. The product comes in un-coded 2.2 lbs. (1kg) clear plastic package overwrapped with reddish brown paper label.
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·F-1285-2019·2019-04-03

    Surtidoras Bakery Mini-Puff Pastry Ears Recalled for Soy Allergen Mislabeling

    Surtidoras Bakery is recalling Mini-Puff Pastry Ears because the packaging fails to declare soy in the 'Contains' statement, despite listing soybean oil in the ingredients.

    Product
    Mini-Puff Pastry Ears, brand Surtidoras Bakery, net wt. 10.4 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR *** SOYBEAN OIL***". The allergens declared in the CONTAINS statement…
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V269000·2019-04-03

    Weis Fire & Safety Recalls One 2018 Ford F-550 Emergency Vehicle

    Weis Fire & Safety is recalling one 2018 Ford F-550 emergency vehicle because its brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    FORD — FORD F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling 280 Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1058-2019·2019-04-03

    Sunset Compressor Nebulizer Recalled for Overheating and Mouthpiece Detachment Risk

    SANRAI INTERNATIONAL LLC is recalling 150 Sunset Compressor Nebulizer units in South Africa due to voltage incompatibility risks.

    Product
    Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1190-2019·2019-04-03

    Vanns Spices Recalls Casa de Sante Asafetida Powder for Undeclared Gluten

    Vanns Spices is recalling Casa de Sante Asafetida Powder Organic due to undeclared gluten. The recall affects 250 cases sold domestically to one retail account.

    Product
    Casa de Sante, Asafetida Powder Organic, 2.6 oz. (74g) 6 per package
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1196-2019·2019-04-03

    Bauer's Candies Caramels Recalled for Hepatitis A Exposure Risk

    Bauer's Candies, Inc. is recalling Bourbon Sea Salt Caramels due to a risk of Hepatitis A exposure. The product was distributed to retail locations and private individuals in multiple states.

    Product
    Bourbon Sea Salt Bauer's Candies Caramels NET WT 4 oz & 8 oz (bag) & bulk
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-1066-2019·2019-04-03

    Beaver Visitec Soft Tip Cannula Recall for Missing Protective Sheath

    Beaver Visitec is recalling specific lots of Soft Tip Cannulas because a missing protective sheath may cause the silicone tip to break or detach during eye procedures.

    Product
    BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2019·2019-04-03

    Surtidoras Bakery Recalls Kid's Rainbow Cookies for Allergen Labeling Error

    Surtidoras Bakery is recalling 50 packages of Kid's Rainbow Cookies because the packaging failed to declare coconut as an allergen in the 'Contains' statement.

    Product
    Kid's Rainbow Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***ENRICHED WHEAT FLOUR BLEACHED*** SOYBEAN OIL***SOY LECITHIN ***MILK FAT***MODIFIED COCONUT…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1068-2019·2019-04-03

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns

    Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.

    Product
    Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2019·2019-04-03

    LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Risk

    LW Scientific is recalling ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard.

    Product
    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 46 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1051-2019·2019-04-03

    BD Synapsys Laboratory Software Recalled for Incorrect Test Order Association

    Becton Dickinson is recalling BD Synapsys version 2.1 because it allowed test orders to be associated with incorrect culture records.

    Product
    BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2019·2019-04-03

    Medtronic Pulmonary Vein Ablation Catheter Recalled for Phrenic Nerve Injury Risk

    Medtronic is recalling PVAC GOLD catheters to reduce the potential for phrenic nerve injury during cardiac ablation procedures.

    Product
    Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1210-2019·2019-04-03

    Pillsbury Flour Recalled Due to Potential Salmonella Contamination

    Hometown Food Company is recalling Pillsbury Unbleached All Purpose Flour due to potential Salmonella contamination. The product was distributed nationwide.

    Product
    Pillsbury Unbleached All Purpose Flour Enriched 5Lb paper bag retail. 8 bags per shrink wrapped bale wholesale. UPC "0 5150022241 6" - retail unit UPC "0 5150022241 3" - wholesale bale
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2019·2019-04-03

    Accelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results

    Accelerate Diagnostics is recalling 81 Accelerate Pheno systems because rare bacterial isolates may generate incorrect meropenem susceptibility results. A software update suppresses these specific results to mitigate risk.

    Product
    Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2019·2019-04-03

    GE Healthcare Recalls Integrated ECG Cables Due to Short Circuit Risk

    GE Healthcare is recalling 288 integrated ECG cables that can short circuit during defibrillation, potentially diverting 25% of the energy away from the patient.

    Product
    Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2019·2019-04-03

    Philips MX40 Wearable Monitor Batteries Recalled for Manufacturing Defect

    Philips North America is recalling 40 lithium-ion rechargeable batteries for the MX40 Wearable Monitor due to a manufacturing defect that may affect monitor operation.

    Product
    Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1279-2019·2019-04-03

    Surtidoras Bakery Pecan Cookies Recalled for Peanut Oil Allergen Mislabeling

    Surtidoras Bakery is recalling 30 packages of Pecan Cookies because the ingredients list declares peanut oil, but the 'Contains' statement omits it.

    Product
    Pecan Cookies, brand Surtidoras Bakery, net wt. 1.08 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** MILK *** EGGS*** PECANS*** PEANUT OIL ***". The allergens declared in the…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1186-2019·2019-04-03

    Klaire Labs Reduced L-Glutathione Recalled for Containing Lithium Orotate

    ProThera, Inc. is recalling Klaire Labs Reduced L-Glutathione capsules because they are mis-packaged and contain Lithium Orotate instead of the labeled ingredient.

    Product
    Klaire Labs Reduced L-Glutathione 150 mg capsules, single capsule dose 100 vegetarian capsules SKU V799-10 UPC Code: 7 09616 79910 9
    Category
    Drug
    Distribution
    14 states
  • HighFDA (Food)·F-1277-2019·2019-04-03

    Surtidoras Bakery Recalls Kid's Chocolate Cookies for Undeclared Coconut Allergen

    Surtidoras Bakery is recalling 20 packages of Kid's Chocolate Cookies because the packaging fails to declare coconut in the 'Contains' statement, despite listing it in the ingredients.

    Product
    Kid's Chocolate Cookies, brand Surtidoras Bakery, net wt.15.52 oz., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***KIDS CHOCOLATE COOKIES***ENRICHED WHEAT FLOUR BLEACHED*** SOYBEAN OIL***MILK***SOY LECITHIN…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1281-2019·2019-04-03

    Surtidoras Bakery Recalls Vanilla Muffins Due to Undeclared Milk Allergen

    Surtidoras Bakery Inc is recalling 40 packages of Vanilla Muffins distributed in Washington because the packaging failed to declare milk in the 'Contains' statement.

    Product
    Vanilla Muffin, brand Surtidoras Bakery, net wt. 1.74 lbs., packaged in rigid plastic clam shell container. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** SOY LECITHIN ***HOMOGENIZED AND PASTEURIZED MILK 2% REDUCE FAT MILK…
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19V271000·2019-04-03

    Ford E-150 and Transit Vans Recalled for Wheelchair Lift Defect

    Mobility Specialists is recalling 2014-2017 Ford E-150 and Transit vans with wheelchair lifts that may fail, posing a tipping risk to users.

    Product
    FORD — FORD, MOBILITY SPECIALISTS E-150, TRANSIT, FORD E-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2019·2019-04-03

    LW Scientific ZIP IQ PCV Centrifuge Recalled for Rotor Breakage Risk

    LW Scientific is recalling 142 ZIP IQ PCV Centrifuges because the plastic rotor may break and be ejected, posing a safety hazard to technicians.

    Product
    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1280-2019·2019-04-03

    Surtidoras Bakery Recalls Vanilla Pound Cake for Undeclared Milk Allergen

    Surtidoras Bakery Inc is recalling 60 packages of Vanilla Pound Cake because the packaging failed to declare milk in the 'Contains' statement, despite listing it in the ingredients.

    Product
    Vanilla Pound Cake, brand Surtidoras Bakery, net wt. 15 oz., packaged in flexible plastic film wrap. No UPC. The allergens declared in the INGREDIENTS statement: "***UNBLEACHED WHEAT FLOUR *** SOYBEAN OIL***SOY LECITHIN ***HOMOGENIZED AND PASTEURIZED MILK 2% REDUCE FAT MILK…
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19098·2019-04-03

    Matco Tools Wireless Chargers Recalled Due to Burn Hazard

    Professional Tool Products is recalling Matco Tools wireless chargers because they can overheat and cause burns. Consumers should stop using them and return them for a refund.

    Product
    Matco Tools wireless chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2019·2019-04-03

    LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Hazard

    LW Scientific is recalling 16 ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard to technicians.

    Product
    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2019·2019-04-03

    Philips MultiDiagnost Eleva Imaging System Recalled for Missing Locking Plate

    Philips is recalling MultiDiagnost Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2019·2019-04-03

    Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use

    Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.

    Product
    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2019·2019-04-03

    Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch

    Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.

    Product
    JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1047-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 207 Bone Harvesters due to a breach in the sterile barrier pouch that may compromise device sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2019·2019-04-03

    Avitus Bone Harvester Recalled for Potential Sterility Compromise

    Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's sterility.

    Product
    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2019·2019-04-03

    Philips URODiagnost Eleva X-ray System Recalled for Missing Locking Plate

    Philips North America, LLC is recalling URODiagnost Eleva X-ray systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2019·2019-04-03

    Philips MultiDiagnost-Eleva Imaging System Recalled for Missing Locking Plate

    Philips is recalling MultiDiagnost-Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

    Product
    MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2019·2019-04-03

    Kendall SCD Express Sterile Sleeves Recalled for Sterility Failure

    COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.

    Product
    Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1056-2019·2019-04-03

    Allergan Recalls 72 Bottles of Combigan Eye Drops for cGMP Deviations

    Allergan is voluntarily recalling 72 bottles of Combigan ophthalmic solution in Tennessee due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    COMBIGAN — COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1057-2019·2019-04-03

    Lupin Recalls Fayosim Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.

    Product
    Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1062-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver

    Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1060-2019·2019-04-03

    Ecolab Gel Hand Sanitizer Recalled for Chemical Contamination

    Ecolab Inc. is recalling specific lots of Ecolab Gel Hand Sanitizer due to the presence of low levels of substituted benzene compounds.

    Product
    ECOLAB — ECOLAB (ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1064-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the oversized feature makes it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1063-2019·2019-04-03

    Ecolab Recalls Quick-Care Foam Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling 67 units of Quick-Care Foam Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.

    Product
    Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1061-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers

    Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits because the 1.25mm Hex Drivers may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1061-2019·2019-04-03

    Ecolab Recalls Advanced Gel Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling Advanced Gel Hand Sanitizer because low levels of substituted benzene compounds were found after complaints of malodor.

    Product
    ADVANCED GEL HAND SANITIZER — ADVANCED GEL HAND SANITIZER (ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1057-2019·2019-04-03

    Randox Blood Gas Control Level 2 Recalled for pH Range Error

    Randox Laboratories is recalling Blood Gas Control Level 2 kits due to an error in the assignment of the control range pH.

    Product
    Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1063-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1241-2019·2019-04-03

    Kroger Recalls 16 oz Quinoa Packages for Possible Pesticide Contamination

    The Kroger Company is recalling 16 oz packages of quinoa due to possible contamination with pesticide. Consumers should check their pantries for the specific best-by dates listed.

    Product
    Quinoa, 16 oz plastic package
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1064-2019·2019-04-03

    Ecolab Recalls Express Gel Hand Sanitizer Due to Chemical Contamination

    Ecolab is recalling 105 bottles of Express Gel Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.

    Product
    Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1058-2019·2019-04-03

    Ingenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles

    Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
    Category
    Drug
    Distribution
    Distributed nationwide

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