The Recall Desk

Archive

September 2019 recalls

454 recalls were announced in September 2019.

What the numbers show

Critical
36
Severe
148
High
192
Moderate
64
Low
14

Of the 454 recalls this month scored against our rubric, 8% are Critical, 33% are Severe.

Which agencies issued them

101–200 of 454

  • SevereFDA (Drugs)·D-1859-2019·2019-09-25

    Superior Pain & Itch Relief Lidocaine Gel Recalled for Contamination

    Ridge Properties, LLC is recalling Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, because the product was found to be contaminated and above specification for lidocaine assay.

    Product
    Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2162-2019·2019-09-25

    Pita Pal Foods Recalls Fresh Thyme Hummus Due to Listeria Risk

    Pita Pal Foods LP is recalling Fresh Thyme Original Hummus with Pretzels because the product has the potential to be contaminated with Listeria monocytogenes.

    Product
    Fresh Thyme Original Hummus with Pretzels 4.1 oz. UPC 41330 11210 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2243-2019·2019-09-25

    Publix Pumpkin Pie Recalled for Lead and Metal Fragments

    Weston Foods is recalling Publix 8-inch pumpkin pies due to the presence of lead and metal pieces ranging from 0.5mm to 2.0mm.

    Product
    Publix 8 inch T/S pumpkin pie US; 623g (22 oz. or 1 LB 6 oz.), Carton, 6 units per case
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-2170-2019·2019-09-25

    Pita Pal Foods Recalls Roasted Garlic Hummus Due to Listeria Risk

    Pita Pal Foods LP is recalling 840 cases of Roasted Garlic Hummus nationwide due to potential Listeria monocytogenes contamination.

    Product
    Hummus Hummus Roasted Garlic Hummus 10 oz. UPC 851351007695 packaged in Plastic tub with clear lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1869-2019·2019-09-25

    Aurolife Recalls Fexofenadine Tablets Due to Impurity Failures

    Aurolife Pharma is recalling equate Allergy Relief tablets because they failed impurity and degradation specifications.

    Product
    Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1863-2019·2019-09-25

    West-Ward Recalls Oxcarbazepine Oral Suspension Due to Impurity Failures

    West-Ward Columbus Inc is recalling specific lots of Oxcarbazepine Oral Suspension because they failed impurity and degradation specifications.

    Product
    Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2199-2019·2019-09-25

    PitaPal Organic Cilantro Jalapeno Hummus Recalled for Listeria Risk

    Pita Pal Foods LP is recalling PitaPal Organic Cilantro Jalapeno Hummus due to potential Listeria monocytogenes contamination.

    Product
    PitaPal Organic Cilantro Jalapeno Hummus 10 oz. UPC 851570003348 packaged in Plastic tub with clear lid with green rim.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2231-2019·2019-09-25

    Ore Ida Spud Bites Recalled Due to Hard Foreign Material Presence

    McCain Foods USA is recalling Ore Ida Spud Bites because they may contain hard foreign material. The product was distributed to foodservice wholesalers and restaurant distribution centers.

    Product
    Ore Ida Spud Bites, packaged in 5lb. plain poly foodservice bags, six bags per case, frozen, Case UPC: 1 00 72714 00093 2. SKU: OIF00093A
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2232-2019·2019-09-25

    Stavis Seafoods Recalls MiCal Yellowfin Tuna Poke Cubes Due to Histamine

    Stavis Seafoods, Inc. is recalling MiCal brand Yellowfin Tuna Poke Cubes because the product may contain elevated levels of histamine.

    Product
    MiCal brand YELLOWFIN TUNA POKE CUBE, Raw, Frozen, Product of Vietnam, Wild Caught. Cube size - 1 inch (2cm x 2cm) AAA grade. Product is packed in 1lb vacuum packed bags in a pre-printed labeled master case. Master case weight is 5lbs.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2541-2019·2019-09-25

    Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Misassembly

    Wilson-Cook Medical Inc. is recalling 160 units of Hemospray Endoscopic Hemostat because misassembly may prevent the device from spraying powder.

    Product
    Hemospray Endoscopic Hemostat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2019·2019-09-25

    Maquet Cardiopulmonary Sets Recalled Due to Incorrect Quick Connector Assembly

    Maquet is recalling 54 cardiopulmonary sets because quick connectors were assembled in reverse, preventing proper priming and function.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
    Category
    Medical Device
    Distribution
    17 states
  • HighNHTSA·19V679000·2019-09-25

    Volkswagen Recalls Multiple Models Due to Regulatory Non-Compliance

    Volkswagen is recalling specific 2007-2019 models because internal evaluation modifications may cause non-compliance with regulatory requirements, potentially increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN, PASSAT, JETTA HYBRID, BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2019·2019-09-25

    Ad-Tech Drill Sleeve Guides Recalled for Potential Drill Bit Seizure

    Ad-Tech Medical Instrument Corporation is recalling specific Drill Sleeve Guides because the inner diameter was under tolerance, which could cause the drill bit to seize during surgery.

    Product
    AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-2158-2019·2019-09-25

    House of Spices India Recalls MDH Sambar Masala for Salmonella

    House of Spices India, Inc. is recalling MDH Sambar Masala spice boxes because the product tested positive for Salmonella upon arrival in the United States.

    Product
    MDH Sambar Masala; Spices blend for South Indian Cuisine 3.5 oz. (100 g) box. code 6291103750327 Ingredients: coriander, Chili Rec, Cumin Powder, Tumeric, Salt White, Fenugreek seeds, Mustard, Lentil (Chana Dal) Lentil (Pigeon peas lentil) Black Pepper, Fennel, Cassia…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2543-2019·2019-09-25

    Boston Scientific Recalls S-ICD Devices Due to Battery Depletion

    Boston Scientific is recalling 404 EMBLEM MRI S-ICD devices because a compromised electrical component causes accelerated battery depletion, potentially requiring earlier replacement.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2019·2019-09-25

    Boston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators

    Boston Scientific is recalling 28 EMBLEM S-ICD devices due to accelerated battery depletion. Patients should contact their healthcare provider for evaluation.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2019·2019-09-25

    Philips IntelliVue Remote Antenna Cable Recalled for Incorrect Rating

    Philips is recalling IntelliVue 1.4 GHz Remote Antenna cables used with MX40 monitors because they lack the required rating for some installations.

    Product
    IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2157-2019·2019-09-25

    La Orocovena Biscuit Recalls Coconut Macaroons for Undeclared Dyes

    La Orocovena Biscuit de PR, Inc. is recalling Coconut Macaroons because they contain undeclared FD&C Yellow #5 and FD&C Yellow #6.

    Product
    Coconut Macaroons "Besitos de Coco" packaged in 6 oz. clamshell containers with brand name La Orocovena Biscuit.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1862-2019·2019-09-25

    Torrent Pharma Recalls Anagrelide Capsules Due to Impurity Failures

    Torrent Pharma Inc. is recalling 2,472 bottles of Anagrelide Capsules because routine stability testing detected high levels of impurities.

    Product
    ANAGRELIDE — ANAGRELIDE (ANAGRELIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1870-2019·2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets for Impurity Failures

    Aurolife Pharma is recalling specific lots of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1865-2019·2019-09-25

    Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

    Aurolife Pharma is recalling specific lots of Allergy Relief (Fexofenadine Hydrochloride) 180 mg tablets because they failed impurities and degradation specifications.

    Product
    Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2159-2019·2019-09-25

    Martin's Potato Rolls Recalled for Potential Water Softener Contamination

    Martin's Famous Pastry Shoppe is recalling 8 Sandwich Potato Rolls due to a potential introduction of cation exchange resin, a brown water softener, during production.

    Product
    Martin's 8 Sandwich POTATO ROLLS NET WT. 15oz (425 GRAMS) plastic bag MARTIN'S PASTRY SHOPPE, INC. 1000 Potato Roll Lane Chambersburg, PA 17202-8897 UPC 0 75185 00003 9
    Category
    Food
    Distribution
    4 states
  • LowFDA (Devices)·Z-2545-2019·2019-09-25

    CooperSurgical Recalls LEEP Return Patient Pads Due to Expiration Date Errors

    CooperSurgical is recalling LEEP Return Patient Pads because the expiration dates on the outer boxes have the month and day reversed compared to the individual pouches.

    Product
    LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V676000·2019-09-23

    Mercedes-Benz Recalls E-Class Wagons Due to Rear Spoiler Detachment Risk

    Mercedes-Benz is recalling specific 2017-2019 E-Class wagons because the rear spoiler may detach while driving, creating a road hazard and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450, E63S, E 400, E400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V674000·2019-09-23

    Spartan Metrostar and Gladiator Recall for Air Brake Control Line Defect

    Spartan is recalling 2004-2020 Metrostar and Gladiator vehicles because unprotected air brake control lines may cause unexpected brake application and increase crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V673000·2019-09-23

    Pleasure Way Recalls 2018-2020 Motorhomes for Awning Drive Mechanism Failure

    Pleasure Way is recalling 2018-2020 Plateau, Ascent, and Lexor motorhomes because the awning drive mechanism may fail, causing the awning to extend unexpectedly.

    Product
    PLEASURE WAY — PLEASURE WAY PLATEAU, ASCENT, LEXOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V668000·2019-09-20

    Forest River Recalls 2020 Cherokee Trailers Due to Wiring Exposure

    Forest River is recalling 2020 Cherokee trailers because missing protective paneling exposes distribution panel wiring, increasing the risk of electrical shock or fire.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V675000·2019-09-20

    Ducati Recalls 2014-2018 Motorcycles Due to Engine Oil Leak Risk

    Ducati is recalling 651 motorcycles because engine oil may leak into the airbox and drip onto the rear tire, increasing crash risk.

    Product
    DUCATI — DUCATI 1199, 1299, PANIGALE R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·093-2019·2019-09-20

    Frozen Chicken Entrees Recalled for Misbranding and Undeclared Soy Allergen

    Astrochef LLC is recalling frozen chicken entrees labeled as beef due to misbranding and undeclared soy. No adverse reactions have been reported.

    Product
    Pegasus Foods Inc. — Astrochef LLC. Recalls Chicken Pub Style Entrees Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·19V667000·2019-09-19

    GM Recalls 2019-2020 Chevrolet Equinox AWD for Fuel Tank Leak Risk

    General Motors is recalling 2019-2020 Chevrolet Equinox all-wheel drive vehicles because improperly sealed fuel tank seams may leak fuel, increasing fire risk.

    Product
    CHEVROLET — CHEVROLET EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E064000·2019-09-19

    GM Recalls Chevrolet Camaro Replacement Ignition Keys

    General Motors is recalling replacement flip-key ignition transmitters for 2010-2015 Chevrolet Camaros because the keys may accidentally turn off the engine, causing loss of power steering and braking.

    Product
    CHEVROLET — CHEVROLET CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19781·2019-09-19

    Chronicle Recalls Power Armor Helmets Due to Mold Exposure Risk

    Chronicle LLC is recalling T-51b Power Armor Collectible Helmets sold by GameStop because mold may be present on the fabric liner, posing a risk of respiratory or other infections.

    Product
    Power Armor Collectible Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19780·2019-09-19

    Exploding Kittens Recalls Safety Goggles Sold with Dodgeball Game Sets

    Exploding Kittens is recalling safety goggles sold with Extreme Edition Dodgeball game sets due to a laceration hazard from glass lenses.

    Product
    Safety Goggles sold with Throw Throw Burrito Extreme Going Pro Edition Dodgeball Card Game sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0003-2020·2019-09-18

    QQ Fish Mushroom Fish Ball Recalled for Undeclared Egg Allergen

    Great One Trading Inc. is recalling QQ Fish brand Mushroom Fish Ball because the product contains undeclared egg. The recall affects 2,000 packets distributed in Massachusetts, Pennsylvania, and Connecticut.

    Product
    QQ Fish brand Mushroom Fish Ball, 200g
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-2314-2019·2019-09-18

    Teleflex Medical Recalls Sheridan Preformed Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Hudson RCI Sheridan Preformed tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1879-2019·2019-09-18

    Plastikon Recalls Milk of Magnesia Unit Dose Cups for Microbial Contamination

    Plastikon Healthcare LLC is recalling specific lots of Milk of Magnesia unit dose cups because they failed bioburden testing for Total Aerobic Microbial Count.

    Product
    Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2452-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan is recalling 4 million textured breast implants worldwide after FDA safety updates linked them to a higher incidence of anaplastic large cell lymphoma.

    Product
    Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2457-2019·2019-09-18

    Allergan Natrelle Tissue Expanders Recalled for Lymphoma Risk

    Allergan is recalling Natrelle 133 tissue expanders due to FDA safety information regarding a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.

    Product
    Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2460-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan is recalling specific textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2019·2019-09-18

    Aesculap Caiman Disposable Surgical Instrument Recalled for Sterility Concerns

    Aesculap Implant Systems LLC is recalling Caiman disposable articulated instruments due to a possibility that the sterility batch was insufficiently sterilized.

    Product
    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1850-2019·2019-09-18

    FDA Recalls Bevacizumab Intravitreal Injection Due to Sterility Concerns

    AmEx Pharmacy is recalling Bevacizumab intravitreal injections because the product lacks assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.

    Product
    Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2451-2019·2019-09-18

    Allergan Recalls Natrelle Textured Breast Implants Due to Lymphoma Risk

    Allergan PLC is recalling Natrelle textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.

    Product
    Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2453-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan is recalling textured Natrelle Inspira breast implants and tissue expanders following FDA safety updates linking these devices to a higher incidence of anaplastic large cell lymphoma.

    Product
    Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1849-2019·2019-09-18

    AmEx Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns

    Pacifico National, Inc. dba AmEx Pharmacy is recalling Bevacizumab intravitreal injections because of a lack of assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.

    Product
    Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2311-2019·2019-09-18

    Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2456-2019·2019-09-18

    Allergan Recalls Natrelle Tissue Expanders Due to Lymphoma Risk

    Allergan is recalling Natrelle tissue expanders because the FDA identified a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.

    Product
    Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1852-2019·2019-09-18

    Pfizer Recalls Bacteriostatic Water Vials Due to Sterility Concerns

    Pfizer is recalling 185,700 vials of Bacteriostatic Water for Injection due to a lack of assurance of sterility. The product was distributed nationwide in the US and Puerto Rico.

    Product
    BACTERIOSTATIC WATER — BACTERIOSTATIC WATER (BACTERIOSTATIC WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2123-2019·2019-09-18

    Bubbies Ice Cream Products Recalled for Foreign Plastic Pieces

    Bubbies is recalling Mochi and Cookie Dough Ice Cream Bites due to potential foreign plastic pieces. The recall covers products distributed nationwide and to Russia and Lebanon.

    Product
    Bubbies Cookie Dough Ice Cream Bites -Chocolate Chip Item Code CDR00002, UPC Code 50013-1, UPC GTIN 10787325500138. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2463-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan PLC is recalling specific textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2462-2019·2019-09-18

    Allergan Recalls Textured Silicone-Filled Breast Implants Due to Lymphoma Risk

    Allergan PLC is recalling specific textured silicone-filled breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V661000·2019-09-18

    4-Star Horse Trailer Recall for Insufficient Axle Bearing Grease

    4-Star Trailers is recalling 2019 horse trailers because axle bearings may lack proper grease, increasing the risk of wheel lockup and crashes.

    Product
    4-STAR TRAILER — 4-STAR TRAILER HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2317-2019·2019-09-18

    Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is recalling Sheridan/CF Novaplus 7.0 mm tracheal tubes because the Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V663000·2019-09-18

    Isuzu NPR, NQR, and NRR Recall for Dual Steering Keystock Defect

    Diesel Modification Center is recalling 2018-2019 Isuzu NPR, NQR, and NRR vehicles modified with dual steering because a keystock may dislodge, causing loss of steering.

    Product
    ISUZU — ISUZU NRR, NQR, NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2464-2019·2019-09-18

    Allergan Textured Breast Implants Recalled Due to Lymphoma Risk

    Allergan is recalling textured breast implants and tissue expanders following FDA safety updates regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2155-2019·2019-09-18

    Krasnyi Oktyabr Recalls Dried Fruits for Undeclared Sulfites

    Krasnyi Oktyabr Inc. USA is recalling Tainy Vostoka Assorted Dried Fruits - Apple because the product contains undeclared sulfites.

    Product
    TAINY VOSTOKA ASSORTED DRIED FRUITS -APPLE were distributed nationwide in retail stores and through mail orders. The product comes in 500gram (17.65 oz), clear plastic package marked with container code #15 03 2019 SS. The text on the label is written in Russian.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2455-2019·2019-09-18

    Allergan Recalls Natrelle Textured Breast Implants and Tissue Expanders

    Allergan PLC is recalling Natrelle 133 tissue expanders due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) associated with textured breast implants.

    Product
    Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2252-2019·2019-09-18

    High Liner Salmon Fillets Recalled for Listeria monocytogenes Contamination

    High Liner Foods is recalling Sea Cuisine Citrus Herb Rubbed Salmon after FDA samples tested positive for Listeria monocytogenes.

    Product
    Sea Cuisine Citrus Herb Rubbed Salmon. Two Atlantic salmon fillets with lemon, herb, sea salt, and pepper; NET WT 8 OZ (227 g); KEEP FROZEN; Cooking instructions included - " be sure to cook to a minimum temperature of 165F before enjoying"
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2459-2019·2019-09-18

    Allergan Recalls McGhan BioDIMENSIONAL Silicone-Filled Breast Implants

    Allergan PLC is recalling McGhan BioDIMENSIONAL silicone-filled breast implants due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) associated with textured implants.

    Product
    McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2315-2019·2019-09-18

    Teleflex Recalls Hudson RCI Sheridan Uncuffed Tracheal Tubes

    Teleflex Medical is recalling Hudson RCI Sheridan Uncuffed tracheal tubes because specific lots of the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·19206·2019-09-18

    Kichler Elan Shayla Mini Pendant Lights Recalled for Fire Hazard

    Kichler Lighting is recalling Elan Shayla Mini Pendant Lights because the sockets can overheat and catch fire. Consumers should stop using the fixtures and contact Kichler for a free replacement.

    Product
    Elan Shayla Mini Pendant Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2465-2019·2019-09-18

    Allergan Textured Breast Implants Recalled Due to Lymphoma Risk

    Allergan is recalling textured breast implants worldwide due to an increased risk of anaplastic large cell lymphoma (BIA-ALCL). Patients should consult their healthcare providers.

    Product
    Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V664000·2019-09-18

    Subaru Recalls 2020 Legacy and Outback for Brake Pedal Bolt Issue

    Subaru is recalling 2020 Legacy and Outback vehicles because a missing or loose brake pedal bolt may reduce braking performance and increase crash risk.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2313-2019·2019-09-18

    Teleflex Recalls Sheridan EZ-ENDO Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan EZ-ENDO tracheal tubes because the 15 mm connector may disconnect, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2461-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan is recalling 4 million textured breast implants and tissue expanders worldwide due to an increased risk of anaplastic large cell lymphoma.

    Product
    Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2318-2019·2019-09-18

    Teleflex Recalls Sheridan/HVT Novaplus Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan/HVT Novaplus tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V665000·2019-09-18

    Mercedes-Benz and Freightliner Sprinter Recalled for Hood Latch Defect

    Daimler Vans USA is recalling 2018-2019 Sprinter vans because an improperly tightened hood screw may allow the hood to open while driving, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 4500, SPRINTER 1500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2316-2019·2019-09-18

    Teleflex Medical Recalls Hudson RCI Sheridan/HVT Tracheal Tubes

    Teleflex Medical is recalling specific lots of Hudson RCI Sheridan/HVT tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2454-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan PLC is recalling specific textured breast implants and tissue expanders due to a higher incidence of anaplastic large cell lymphoma (BIA-ALCL).

    Product
    Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2312-2019·2019-09-18

    Teleflex Medical Recalls Hudson RCI Sheridan/CF Tracheal Tubes

    Teleflex Medical is recalling Hudson RCI Sheridan/CF tracheal tubes because specific lots of the 15 mm Sheridan connector may disconnect from the endotracheal tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2156-2019·2019-09-18

    Krasnyi Oktyabr Recalls Dried Quince for Undeclared Sulfites

    Krasnyi Oktyabr Inc. USA is recalling 740 units of TAINY VOSTOKA Assorted Dried Fruits - Quince because the product contains undeclared sulfites.

    Product
    TAINY VOSTOKA ASSORTED DRIED FRUITS - QUINCE packaged in 500gram (17.65oz), clear plastic package marked with container code #24 02 2019 SS. The text on the package is written in Russian.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-2145-2019·2019-09-18

    Kashat Wholesale Recalls Ground Cinnamon Due to Lead Contamination

    Kashat Wholesale, Inc. is recalling 360 units of 4oz ground cinnamon because positive samples for lead were found in bulk cinnamon.

    Product
    Ground Cinnamon 4oz plastic container 24 containers per wholesale case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2516-2019·2019-09-18

    Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue

    Zimmer Biomet is recalling 86 units of the XP-XP Tibial Tray because the locking bar may not fully engage. The recall covers units distributed across the US and several international regions.

    Product
    XP-XP Tibial Tray - Interlok 91mm Item # 195761
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2458-2019·2019-09-18

    Allergan Recalls McGhan Tissue Expanders Due to Lymphoma Risk

    Allergan is recalling McGhan Croissant-Shaped Tissue Expanders because the FDA identified a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.

    Product
    McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2019·2019-09-18

    Zimmer Biomet Recalls XP-XP Tibial Trays Due to Locking Bar Defect

    Zimmer Biomet is recalling specific XP-XP Tibial Trays because the locking bar may not fully engage. The recall covers units distributed in the US and several international regions.

    Product
    XP-XP Tibial Tray - Interlok 79 mm Item # 195758
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-2126-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Plastic Contamination

    Bubbies is recalling Mochi Ice Cream and related products due to the potential for free-floating foreign plastic pieces in the product.

    Product
    Bubbies Mochi Ice Cream -Chocolate Coconut Item Code CS812067, UPC Code 20203-5, UPC GTIN 10787325202032. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2019·2019-09-18

    Zeus Scientific Recalls Dynex DSX Software for False Negative ELISA Results

    Zeus Scientific is recalling 28 Dynex DSX software files due to a programming error that causes false negative results in specific ELISA assays.

    Product
    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2125-2019·2019-09-18

    Bubbies Mochi Ice Cream Recalled for Potential Foreign Plastic Pieces

    Bubbies is recalling Mochi Ice Cream and Cookie Dough Ice Cream Bites due to potential free-floating foreign plastic pieces.

    Product
    Bubbies Mochi Ice Cream -Blood Orange Item Code CS800490, UPC Code 20085-7, UPC GTIN 10787325200854. Product is packed in oriented polystyrene sheet (OPS) thermo-formed 6-cavity trays, tray is packed in 6 count boxes.
    Category
    Food
    Distribution
    Distributed nationwide

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