The Recall Desk

Archive

March 2020 recalls

515 recalls were announced in March 2020.

What the numbers show

Critical
16
Severe
165
High
214
Moderate
96
Low
24

Of the 515 recalls this month scored against our rubric, 3% are Critical, 32% are Severe.

1–100 of 515

  • SevereNHTSA·20E018000·2020-03-31

    Cummins Recalls B6.7 Diesel Engines Due to Fuel Heater Fire Risk

    Cummins is recalling specific B6.7 diesel engines used in school buses, trucks, and emergency vehicles because the fuel heater may overheat, melt, or cause a fire.

    Product
    FUEL SYSTEM, DIESEL: PRE-HEATER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V189000·2020-03-31

    Subaru Recalls 2019 Crosstrek Vehicles for Rear Seat Belt Defect

    Subaru is recalling 2019 Crosstrek vehicles because the rear seat belt locking mechanism may not function as intended, increasing injury risk in crashes.

    Product
    SUBARU — SUBARU CROSSTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V188000·2020-03-30

    Nissan Recalls NV, Titan, Armada, QX56 for Air Bag Inflator Defect

    Nissan is recalling 216,678 vehicles from 2011-2017 because the driver-side air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    INFINITI — INFINITI, NISSAN QX56, NV, ARMADA, TITAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V186000·2020-03-27

    Can-Am Recalls 2020 Spyder RT Motorcycles Due to Brake Failure Risk

    Bombardier is recalling 2020 Can-Am Spyder RT motorcycles because a brake support could break during emergency braking, causing total loss of braking ability.

    Product
    CAN-AM — CAN-AM SPYDER RT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V183000·2020-03-26

    Chrysler Recalls 2019 Jeep Grand Cherokee and Dodge Durango for Driveline Defect

    Chrysler is recalling 2019 Jeep Grand Cherokee and Dodge Durango vehicles because insufficiently hardened front differential pinion gears can wear down, leading to a loss of power or the PARK function.

    Product
    JEEP — JEEP, DODGE GRAND CHEROKEE, DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E017000·2020-03-26

    Land Rover Recalls 2020 Range Rover Evoque Headliners for Safety Defect

    Land Rover is recalling 2020 Range Rover Evoque vehicles because some headliners lack a required metal plate, potentially reducing head impact protection in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V185000·2020-03-26

    BMW Recalls 328d Vehicles for Driveline Joint Defect

    BMW is recalling 2013-2016 328d xDrive vehicles because a driveline joint may fail, causing loss of rear power and increasing crash risk.

    Product
    BMW — BMW 328D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V180000·2020-03-26

    2019 Mercedes-Benz and Freightliner Sprinter Recall for Manual Error

    Daimler Vans USA is recalling 2019 Sprinter vans because the Operator's Manual may contain incorrect information about the automatic parking function, potentially increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 1500, SPRINTER 2500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V184000·2020-03-26

    GM Recalls 2019-2020 Chevrolet Bolt EV for Rear Door Cable Defect

    General Motors is recalling 2019-2020 Chevrolet Bolt EVs because a rear door cable may be too long, potentially causing the door to open unintentionally while driving.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0860-2020·2020-03-25

    Chicago Indoor Garden Recalls Sprout Salad Due to E. coli Outbreak

    Chicago Indoor Garden, Inc. is recalling Sprout Salad 6 oz. because FDA analysis found E. coli and linked the product to an outbreak.

    Product
    Sprout Salad 6 oz. Product contains red clover sprouts.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0859-2020·2020-03-25

    Chicago Indoor Garden Recalls Spring Salad Sprouts Due to E. coli

    Chicago Indoor Garden, Inc. is recalling Spring Salad 6 oz. containing red clover sprouts because FDA testing found E. coli and linked the product to an outbreak.

    Product
    Spring Salad 6 oz. Product contains red clover sprouts.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0858-2020·2020-03-25

    Chicago Indoor Garden Recalls Red Clover Products Due to E. coli

    Chicago Indoor Garden, Inc. is recalling Red Clover products because FDA analysis found E. coli and linked the firm to an outbreak.

    Product
    Red Clover 4 oz, Red Clover 2 Lbs. Products have Red Clover as an ingredient.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1036-2020·2020-03-25

    UP2 Libido Supplement Recalled for Undeclared Sildenafil

    Med Man Distribution is recalling UP2 dietary supplements because FDA analysis found undeclared sildenafil, a prescription drug, in the product.

    Product
    UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0843-2020·2020-03-25

    Vita Wild Herring in Wine Sauce Recalled for Undeclared Milk

    Vita Food Products, Inc. is recalling 8,370 units of Vita Wild Herring in Wine Sauce due to undeclared milk, a major allergen.

    Product
    Vita Wild Herring in Wine Sauce 32oz plastic jar, UPC 22635 40011, 6 jars per case Ready to Eat Keep Refrigerated
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0861-2020·2020-03-25

    Chicago Indoor Garden Recalls Mixed Greens Contaminated with E. coli

    Chicago Indoor Garden is recalling Mixed Greens containing red clover sprouts because FDA testing found E. coli. The product was distributed nationwide, primarily through Whole Foods.

    Product
    Mixed Greens 4 oz. Product contains red clover sprouts.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1499-2020·2020-03-25

    Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.

    Product
    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1012-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Regular Strength Acid Reducer (Ranitidine) tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0845-2020·2020-03-25

    Moonstruck Chocolate Recalls Praline Pecan Bars for Undeclared Milk

    Moonstruck Chocolate Company is recalling Praline Pecan & Ginger Element Bars due to undeclared milk, a major allergen.

    Product
    Moonstruck Praline Pecan & Ginger Element Bar in Dark Chocolate, packaged first into a clear poly film that is sealed. The sealed bar is then packed into a cardboard box (1 bar per box) that has label information. Net wt. 3.1 oz. The product SKU number is 312806 and the UPC code
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1019-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pha
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1031-2020·2020-03-25

    Mylan Recalls Sotalol HCL Tablets Due to Metal Particles

    Mylan Pharmaceuticals is recalling Sotalol HCL 80 mg tablets because of the presence of metal particles. The affected lot was distributed nationwide.

    Product
    Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1020-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1033-2020·2020-03-25

    Sun Pharmaceutical Recalls Doxycycline Capsules Due to Manufacturing Deviations

    Sun Pharmaceutical Industries is recalling 172,320 bottles of Doxycycline Capsules, 100 mg, because they were not manufactured under Current Good Manufacturing Practice conditions.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1015-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1027-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2020·2020-03-25

    Bow and Arrow Libido Supplement Recalled for Undeclared Sildenafil

    Med Man Distribution is recalling Bow & Arrow dietary supplements because they contain undeclared sildenafil, a prescription drug ingredient not listed on the label.

    Product
    Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1021-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo is recalling Maximum Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1017-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1024-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential Impurity Contamination

    Perrigo is recalling specific lots of Maximum Strength Acid Reducer ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V181000·2020-03-25

    2019 Freightliner and Mercedes-Benz Sprinter Brake Hose Recall

    Daimler Vans USA is recalling 2019 Freightliner and Mercedes-Benz Sprinter vans because a fender liner may chafe the brake hose, risking brake fluid loss and increased stopping distance.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 4500, SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1030-2020·2020-03-25

    Lisinopril/HCTZ Tablets Recalled Due to Foreign Tablet Presence

    RemedyRepack Inc. is recalling Lisinopril/HCTZ tablets because a foreign Fenofibrate tablet was found in the product bottle.

    Product
    Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1026-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1506-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.

    Product
    DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1016-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1508-2020·2020-03-25

    Stryker Strykeprobe Outer Sheath Recalled for Potential Electrical Hazard

    Stryker is recalling 525 Strykeprobe Outer Sheath Replacement devices due to a potential length mismatch that could cause sheath melting and unintended electrical flow to patients.

    Product
    Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PK
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1013-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer (Ranitidine 75 mg) tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1028-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1025-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchang
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1014-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Regular Strength Acid Reducer Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0836-2020·2020-03-25

    Juanita's Foods Recalls Hot & Spicy Menudo for Metal Contamination Risk

    Juanita's Foods is recalling Hot & Spicy Menudo cans because a small amount of product held for potential metal contamination was released into distribution.

    Product
    Juanita's Foods Hot & Spicy Menudo; Picoso; 25 oz.( 1 lb. 9oz.) 709 grams UPC: 70132 00201 Juanita's Foods, Wilmington, CA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1023-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 3680
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2020·2020-03-25

    CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.

    Product
    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0844-2020·2020-03-25

    Pero Family Farms Zucchini Spiral Pesto Recalled for Undeclared Allergens

    Pero Family Farms is recalling Zucchini Spiral Pesto kits due to undeclared egg and milk allergens caused by incorrect labeling.

    Product
    Pero Family Farms Fresh n' Savory Simple Side Kit Zucchini Spiral Pesto; 11 oz. EXP 2020-03-20. Cooks in 5 Minutes
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1509-2020·2020-03-25

    Stryker Strykeprobe Outer Sheath Replacement Recalled for Insulation Risk

    Stryker is recalling Strykeprobe Outer Sheath Replacements because a length mismatch could cause the probe to melt, compromising insulation and allowing electricity to flow to the patient.

    Product
    Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip, 02500
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1515-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 21,326 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0840-2020·2020-03-25

    Dole Recalls HEB Tuscan Herb Salad Kits Due to Undeclared Allergens

    Dole Fresh Vegetables Inc is recalling HEB Tuscan Herb Chopped Salad Kits because the included dressing contains peanuts, tree nuts, and wheat not listed on the label.

    Product
    HEB Tuscan Herb Chopped Salad Kit, 12.6 oz. UPC: 0-41220-40989-1
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0838-2020·2020-03-25

    Outshine Pineapple Fruit Bars Recalled for White Plastic Pieces

    Dreyers Grand Ice Cream is recalling Outshine Pineapple Fruit Bars due to consumer complaints of white plastic pieces in the product.

    Product
    Outshine Fruit Bars Pineapple; 6 Fruit Ice Bars; 6x2 5 fl. oz) 14.7 Fl. oz. (435 mL); Package UPC: 041548750958; Case UPC: 10041548750955
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-1495-2020·2020-03-25

    Siemens Artis Q Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2020·2020-03-25

    Aesculap Recalls Knee Implants Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low density polyethylene particles may be present on the surface.

    Product
    COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Containing Non-Sterile Gowns

    Avid Medical is recalling 2,632 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighNHTSA·20V178000·2020-03-25

    Thor Motor Coach motorhomes recalled for faulty rear axle differential

    Thor Motor Coach is recalling certain 2020-2021 motorhomes due to insufficient rear axle differential fluid that could cause driveshaft separation and loss of vehicle drive, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH VEGAS, AXIS, CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 5,004 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0837-2020·2020-03-25

    Dreyers Outshine Strawberry Fruit Bars Recalled for Plastic Contamination

    Dreyers Grand Ice Cream is recalling Outshine Strawberry Fruit Bars due to consumer complaints of white plastic pieces.

    Product
    Outshine Fruit Bars Strawberry; 6 Fruit Ice Bars; 14.7 Fl. oz. (435 mL) UPC: 041548610047 Case UPC: 10041548610044
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-1517-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,644 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1514-2020·2020-03-25

    Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2020·2020-03-25

    Agfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error

    Agfa N.V. is recalling two DR 800 X-ray systems because the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1521-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 628 custom procedure trays because they contain surgical gowns that may not be sterile. This poses a risk of surgical site infection and cross-contamination.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1479-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.

    Product
    COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,906 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1525-2020·2020-03-25

    Medtronic CareLink Encore Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling CareLink Encore 29901 programmers due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2020·2020-03-25

    Siemens Artis Angiography Systems Recalled for Software Movement Blockage

    Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.

    Product
    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0842-2020·2020-03-25

    New Seasons Market Recalls Sesame Sticks Due to Undeclared Allergens

    New Seasons Market LLC is recalling Sesame Sticks because they contain undeclared wheat, sesame, and soybean oil.

    Product
    Sesame Sticks packaged in clear zip tie 5 oz. bags. UPC 8 40600 11010 1. The FRONT side label is read in parts: "***NEW SEASONS ***Sesame Sticks ***". The BACK side label is read in parts: "***Wasabi Peas 840600110101 ***Ingredients: Wasabi Peas (Peas, Corn Starch, Wasabi
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1520-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,001 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1501-2020·2020-03-25

    Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement

    Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.

    Product
    Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2020·2020-03-25

    LivaNova Heater-Cooler System 3T Recalled for NTM Contamination Risk

    LivaNova is recalling Heater-Cooler System 3T units to reduce the risk of NTM contamination by providing validated cleaning and disinfection instructions.

    Product
    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.

    Product
    COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays with Non-Sterile Gowns

    Avid Medical is recalling 400 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1503-2020·2020-03-25

    TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by tra
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1478-2020·2020-03-25

    Aesculap Columbus Knee Implant Components Recalled for LDPE Particles

    Aesculap is recalling Columbus R/PS Tibia Plateau knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2020·2020-03-25

    Siemens IMMULITE 1000 Estradiol Kits Recalled for Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorder
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2020·2020-03-25

    TeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by tra
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1524-2020·2020-03-25

    Medtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling 23,180 CareLink 2090 Programmer devices worldwide due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2020·2020-03-25

    Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software

    Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.

    Product
    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of lif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2020·2020-03-25

    Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage: Tibia-Pl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V179000·2020-03-25

    Gillig Recalls 2012-2020 Low Floor Buses Due to Fire Risk

    Gillig is recalling 8,224 Low Floor buses because improper circuit breaker ratings may increase the risk of a fire.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns

    TeDan Surgical Innovations is recalling Quick Start Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing a risk of infection.

    Product
    DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1519-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 230 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-0839-2020·2020-03-25

    Outshine Fruit Bars Recalled Due to White Plastic Pieces

    Dreyers Grand Ice Cream is recalling Outshine Fruit Bars because consumers reported finding pieces of white plastic in the product.

    Product
    Outshine Fruit Bars - Variety Pack (contains 24 x 5 oz. units) Strawberry, Pineapple, Grape, Tangerine Repack UPC: 041548816678
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-1494-2020·2020-03-25

    Philips Allura Centron X-ray System Recalled for Capacitor Failure

    Philips is recalling 87 Allura Centron X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Cardio Vascular-Allura Centron, system code 722400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2020·2020-03-25

    Binding Site Group Recalls Rheumatoid Factor Kits Due to Calibration Error

    The Binding Site Group is recalling 30 Rheumatoid Factor kits distributed in California because calibration errors may cause falsely abnormal test results.

    Product
    Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1526-2020·2020-03-25

    XTANT Medical Recalls OsteoSelect DBM Putty Due to Volume Discrepancy

    XTANT Medical is recalling 26 units of OsteoSelect DBM Putty because three devices contained 5.0cc instead of the labeled 10.0cc.

    Product
    OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1487-2020·2020-03-25

    Philips Integris Allura X-ray Systems Recalled for Capacitor Failure

    Philips is recalling 70 Integris Allura 15 & 12 X-ray systems because a capacitor may fail, preventing image acquisition.

    Product
    Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1484-2020·2020-03-25

    Materialise Recalls TRUMATCH Orthognathic Surgical Kit Due to Labeling Error

    Materialise N.V. is recalling TRUMATCH Orthognathic surgical kits because the package labeling indicates a different plate than the one actually included.

    Product
    TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1489-2020·2020-03-25

    Philips MultiDiagnost Eleva X-ray System Recalled for Capacitor Failure

    Philips is recalling 534 MultiDiagnost Eleva X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2020·2020-03-25

    Teleflex Pilling Aortic Punch Recalled for Potential Sterile Packaging Compromise

    Deroyal Industries is recalling 669 units of Teleflex Pilling Aortic Punches because the sterile packaging may be compromised, potentially affecting cardiovascular surgical procedures.

    Product
    Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1491-2020·2020-03-25

    Philips Velara X-ray Generator Recalled for Capacitor Failure

    Philips is recalling the Velara X-ray generator because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Poly G Integris H5000, System code 72246
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1051-2020·2020-03-25

    Breckenridge Recalls Solifenacin Succinate Tablets Due to Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling specific lots of Solifenacin Succinate Tablets because manufacturing deviations may have resulted in the production of Solifenacin Tartrate.

    Product
    Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pith
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1045-2020·2020-03-25

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Therapeutics is recalling Daytrana (methylphenidate) transdermal patches because the delivery system failed mechanical peel and shear specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1064-2020·2020-03-25

    Fresenius Recalls Sodium Chloride Injection Bags Due to Sterilization Issue

    Fresenius Medical Care is recalling 32,592 bags of Sodium Chloride 0.9% Injection because chemical indicators were not positioned properly during sterilization.

    Product
    Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1032-2020·2020-03-25

    Sun Pharmaceutical Recalls Doxycycline Capsules Due to Manufacturing Deviations

    Sun Pharmaceutical Industries is recalling 624 bottles of Doxycycline Capsules, 75 mg, because they were not manufactured under Current Good Manufacturing Practice conditions.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2020·2020-03-25

    Philips Allura Exper FD Series X-Ray Generator Recall

    Philips is recalling Allura Exper FD Series X-ray generators because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2020·2020-03-25

    Smith & Nephew Recalls Legion PS Knee Inserts Due to Packaging Error

    Smith & Nephew is recalling 29 Legion PS High Flex XLPE Articular Inserts because they were packaged with an incorrect part.

    Product
    LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1510-2020·2020-03-25

    Arthrex Recalls Low Profile Screws Due to Incorrect Length

    Arthrex, Inc. is recalling 20 units of Low Profile Screws because they are 6 mm longer than intended. The defect may affect bone fixation.

    Product
    Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
    Category
    Medical Device
    Distribution
    6 states

Looking for a different month? Back to 2020.