The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
111
High
490
Moderate
214
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 13% are Severe.

1–100 of 865

  • CriticalFDA (Devices)·Z-0188-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

    Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0067-2019·2018-10-31

    Callie's Charleston Biscuits Recalls Ham Biscuits Due to Listeria Risk

    Callie's Charleston Biscuits is recalling Country Ham Biscuits because the ham used may be contaminated with Listeria monocytogenes.

    Product
    Callie's Charleston Biscuits COUTRY HAM BISCUITS; 18 NET WT. 18 OZ (510 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC 18405 843 577.1198; CALLIESBISCUITS.COM
    Category
    Food
    Distribution
    50 states
  • CriticalFDA (Food)·F-0066-2019·2018-10-31

    Callie's Charleston Biscuits Recalls Ham Biscuits for Listeria Risk

    Callie's Charleston Biscuits is recalling Cocktail Ham Biscuits because the ham used may be contaminated with Listeria monocytogenes.

    Product
    Callie's Charleston Biscuits COCKTAIL HAM BISCUITS; 24 NET WT. 35 OZ (980 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC 18405 843 577.1198; CALLIESBISCUITS.COM
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Devices)·Z-0236-2019·2018-10-31

    GE Medical Systems Recalls Signa Architect MRI Scanners Due to Burn Risk

    GE Medical Systems is recalling four Signa Architect MRI scanners because a small area on the bore surface can get warm enough to cause a serious burn if proper padding is not used.

    Product
    SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0233-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Onions Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted 1/2" Diced Onions; Sold in 25 lb. containers. Brand Name:Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0256-2019·2018-10-31

    McCain Recalls Fire Roasted Diced Button Mushrooms Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Button Mushrooms because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Button Mushrooms: Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereUSDA FSIS·108-2018·2018-10-31

    O Sole Mio Recalls Chicken Tortellini Produced Without Inspection

    Les Aliments O Sole Mio, Inc. is recalling approximately 3,880 pounds of chicken tortellini produced without the benefit of inspection by the Canadian Food Inspection Agency.

    Product
    Les Aliments O Sole Mio, Inc., Recalls Poultry Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0095-2019·2018-10-31

    Pfizer Recalls Meropenem Injection Due to Loss of Sterility Assurance

    Pfizer is recalling 71,075 vials of Meropenem for Injection because the containers may have lost integrity, compromising sterility.

    Product
    Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0237-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Tomatoes Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Tomatoes because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Tomatoes; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0202-2019·2018-10-31

    Boston Scientific Recalls Maestro 4000 Cardiac Ablation Systems Due to RF Energy Issue

    Boston Scientific is recalling Maestro 4000 Cardiac Ablation Systems because radiofrequency energy may continue to deliver after the foot switch is released.

    Product
    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-0061-2019·2018-10-31

    Blackwing Organic Meats Recalls Ground Venison Due to High Lead Levels

    Blackwing Organic Meats, Inc. is voluntarily recalling specific packages of ground venison because they contain high levels of lead.

    Product
    Blackwing Meats. Inc., Ground Venison, 10/1lb, packed in cardboard sleeve/ roll stock film inside, in aRetail Box.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0065-2019·2018-10-31

    Ladyfingers Ham Rolls Recalled for Possible Listeria Contamination

    Ladyfingers Catering is recalling 50,627 packages of Shaved Country Ham Rolls due to potential Listeria monocytogenes contamination.

    Product
    LADYFINGERS GOURMET TO GO SIGNATURE SHAVED COUNTRY HAM ROLLS; ONE DOZEN PER PACKAGE (15oz - 425 grams); ALLERGEN INFORMATION: CONTAINS WHEAT, PRODUCED IN FACILITY THAT PROCESSES PEANUTS AND TREE NUTS. www.ladyfingersofraleigh.com; 919-828-2270; 627 East Whitaker Mill Rd Raleigh,
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·18V770000·2018-10-31

    Forest River Recalls 2018-2019 Buses and RVs for Brake Bolt Issue

    Forest River is recalling 2018-2019 Berkshire RVs and StarTrans/Glaval buses because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    STARTRANS — STARTRANS, FOREST RIVER, GLAVAL BUS PS2, BERKSHIRE, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2019·2018-10-31

    Westlab Pharmacy Recalls Cyclosporine Eye Drops Due to Process Control Issues

    Westlab Pharmacy is recalling Cyclosporine 1% Human Eye Drops due to a lack of process controls. The recall covers nationwide distribution.

    Product
    Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0207-2019·2018-10-31

    McCain Corn and Black Bean Blend Recalled for Listeria and Salmonella

    McCain Foods USA is recalling Corn and Black Bean Blend sold in 2 lb. and 25 lb. packages due to potential Listeria monocytogenes and Salmonella contamination.

    Product
    Corn and Black Bean Blend: Sold in 2 lb. and 25 lb. packages. Brand Name: Jon-Lin¿ NatureSmart¿; Jon-Lin¿, Chef Sensations¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0185-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling CyPass Micro-Stent devices because long-term study data showed statistically significant endothelial cell loss in patients.

    Product
    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0219-2019·2018-10-31

    McCain Recalls Fire Roasted Diced Yellow Peppers Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Yellow Peppers because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Yellow Peppers: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0099-2019·2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling 3,397 bottles of Metformin Hydrochloride Extended Release Tablets, 500 mg, because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V769000·2018-10-31

    Suzuki Recalls 2010-2013 Kizashi Vehicles for Fuel Tank Fire Risk

    Suzuki is recalling 2010-2013 Kizashi vehicles because dust in the vent line may crack the fuel tank, increasing the risk of a fuel leak and fire.

    Product
    SUZUKI — SUZUKI KIZASHI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·107-2018·2018-10-31

    Procesadora La Hacienda Recalls Corned Beef Due to Foreign Matter

    Procesadora La Hacienda, Inc. is recalling ready-to-eat corned beef products that may contain soft plastic or metal. The products were distributed to institutions in Puerto Rico.

    Product
    Procesadora La Hacienda, Inc. — Procesadora La Hacienda, Inc., Recalls Beef Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0232-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Poblano Chiles Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Poblano Chiles because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Poblano Chiles; Sold in 25 lb. containers. Brand Name:Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0243-2019·2018-10-31

    CHS Cotton Tip Applicators Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-0098-2019·2018-10-31

    Teva Recalls Fortamet Extended-Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Fortamet (metformin HCl) extended-release tablets because some may lack laser drilling, potentially affecting drug release.

    Product
    Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0090-2019·2018-10-31

    Westlab Pharmacy Recalls ADAA Cataract Drops Due to Process Control Issues

    Westlab Pharmacy is recalling 222 syringes of ADAA Cataract Drops nationwide due to a lack of process controls.

    Product
    ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0068-2019·2018-10-31

    Cedar's Chickpea Salad Recalled for Undeclared Soy Allergen

    Cedar's Mediterranean Foods is recalling 8oz containers of Chickpea Salad because the product may contain undeclared edamame (soy).

    Product
    Cedar's Chickpea Salad, packaged in an 8oz plastic container, UPC: 044115337767. Product is refrigerated.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Drugs)·D-0097-2019·2018-10-31

    Teva Recalls Paliperidone Extended Release Tablets Due to Missing Laser Drilling

    Teva Pharmaceuticals USA is recalling 3,785 bottles of Paliperidone Extended Release Tablets 9 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0053-2019·2018-10-31

    Sprout Creek Farm Recalls Margie Cheese Due to Improper Pasteurization

    Sprout Creek Farm is recalling Margie Cheese because it was not properly pasteurized. The product was distributed in New York.

    Product
    Margie Cheese, Pasteurized Cow's Milk Cheese, Sprout Creek Farm Poughkeepsie, NY 12603 Plant # 36-8436
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0093-2019·2018-10-31

    RemedyRepack Recalls Amlodipine/Valsartan HCTZ Tablets Due to NDMA Contamination

    RemedyRepack Inc. is recalling Amlodipine/Valsartan HCTZ tablets due to trace amounts of NDMA detected in the active ingredient.

    Product
    Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0198-2019·2018-10-31

    Bovie J-Plasma Precise 360 Handpiece Recalled for Tip Separation Risk

    Bovie Medical Corporation is recalling J-Plasma Precise 360 handpieces because the PEEK tip may separate and remain in patient tissue.

    Product
    J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0238-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Onion and Pepper Blend

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Onion/Pepper Blend because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Onion/Pepper Blend; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0249-2019·2018-10-31

    McCain Recalls Fire-Roasted Diced Tomatillos Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Tomatillos because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Tomatillos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0223-2019·2018-10-31

    McCain Fire-Roasted Vegetable Blend Recalled for Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Vegetable Blend because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Rubio's Vegetable Blend: Sold in 2 lb. Brand Name: Chef Sensations¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0324-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Jalapenos Due to Listeria and Salmonella Risks

    McCain Foods USA is recalling Fire-Roasted 1/4" Diced Jalapenos because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/4" Diced Jalapenos;: Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0216-2019·2018-10-31

    Siemens StreamLab Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling StreamLab Refrigerated Storage Module 9000 units because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    STREAMLAB - REFRIGERATED STORAGE MODULE 9000
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0252-2019·2018-10-31

    McCain Recalls Fire-Roasted Green Jalapeno Slices Due to Listeria and Salmonella

    McCain Foods USA is recalling 14,172 cases of Fire-Roasted Green Jalapeno Slices because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Green Jalapeno Slices; Sold in 20 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0272-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0187-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling the CyPass Micro-Stent because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2019·2018-10-31

    Howmedica Recalls Tritanium TL Steerable Inserter Due to Locking Mechanism Failure

    Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter because the locking mechanism may fail to function as intended due to lack of lubrication.

    Product
    Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0213-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Zucchini Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Half Moon Green Zucchini because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Half Moon Green Zucchini : Sold in 25 lb. and 1200 lb. packaging. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0234-2019·2018-10-31

    Ecolab Recalls Da Vinci Robotic System Disposable Accessory Kits

    Ecolab is recalling specific lots of Disposable Accessory Kits for the Da Vinci Si Robotic system because wrinkles in the packaging seal could compromise sterility.

    Product
    Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic Navigation is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D a
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0217-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Onions Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Onions: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0212-2019·2018-10-31

    McCain GFGB Roasted Vegetable Blend Recalled for Listeria and Salmonella

    McCain Foods USA is recalling GFGB Roasted Vegetable Blend after internal audits revealed products were released with presumptive positive tests for Listeria and Salmonella.

    Product
    Roasted Vegetable Blend: Sold in 2 lb. . packages. Brand Name: GFGB
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0211-2019·2018-10-31

    McCain Foods Recalls Caramelized Diced Onions Due to Listeria and Salmonella

    McCain Foods USA is recalling 77,900 cases of Jon-Lin brand caramelized diced onions because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Caramelized 3/8" Diced Onions: Sold in 25 lb. . packages. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0209-2019·2018-10-31

    McCain Recalls Fire-Roasted Red Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Red Pepper Julienne Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Red Pepper Julienne Strips: Sold in 2 lb. and 25 lb. packages. Brand Name: Jon-Lin¿ NatureSmart¿; Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0276-2019·2018-10-31

    Medtronic O-arm 1000 2nd Edition Imaging System Software Recall

    Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-0220-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Onion and Pepper Strip Blend

    McCain Foods USA is recalling Fire-Roasted Onion/Pepper Strip Blend due to potential Listeria and Salmonella contamination discovered during an internal audit.

    Product
    Fire-Roasted Onion/Pepper Strip Blend: Sold in 20 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0206-2019·2018-10-31

    McCain Recalls Sautéed Diced Onions Due to Listeria and Salmonella Testing Failures

    McCain Foods USA is recalling Sautéed 3/8" Diced Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed 3/8" Diced Onions; Sold in 25 lb. containers. Brand name: Jon-Lin¿, Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0229-2019·2018-10-31

    McCain Foods Recalls Diced Sweet Onions Due to Listeria and Salmonella Testing

    McCain Foods USA is recalling 23,203 cases of Dark Caramelized Diced Sweet Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Dark Caramelized 3/8" Diced Sweet Onions; Sold in 20 lb. containers. Brand Name:Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0327-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Red Jalapeno Slices Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Red Jalapeno Slices because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Red Jalapeno Slices; Sold in 2 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0244-2019·2018-10-31

    McCain Recalls Fire-Roasted Poblano Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Poblano Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Poblano Strips; Sold in 20 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0274-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0215-2019·2018-10-31

    Siemens StreamLab Automation Modules Recalled for Missing Pacemaker Warning Label

    Siemens Healthcare Diagnostics is recalling 186 StreamLab Automation Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    STREAMLAB CORE UNIT / LYNX WITH IOM
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0216-2019·2018-10-31

    McCain Foods Recalls Smokehouse Roasted Diced Apples Due to Pathogen Testing Failures

    McCain Foods USA is recalling Smokehouse Roasted Diced Apples because internal audits revealed products were released after presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Smokehouse Roasted 5/8" Diced Apples: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0243-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Poblanos Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted 1/4" Diced Poblanos because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/4" Diced Poblanos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0240-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 200 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0250-2019·2018-10-31

    CHS Custom Convenience Kits Recalled for Sterility Compromise

    Custom Healthcare Systems is recalling 630 CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0241-2019·2018-10-31

    McCain Recalls Fire-Roasted Pepper and Onion Blend Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire-Roasted Pepper and Onion Blend because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Pepper and Onion Blend; Sold in 300 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0255-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Red Onion and Pepper Blend

    McCain Foods USA is recalling Fire-Roasted Red Onion & Pepper Blend because it was released after presumptive positive tests for Listeria and Salmonella without confirmation.

    Product
    Fire-Roasted Red Onion & Pepper Blend: Sold in 2 lb. containers. Brand Name: Hot Stuff Foods¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0328-2019·2018-10-31

    McCain Foods Recalls Fire-Roasted Diced Red Onions Due to Pathogen Testing Failures

    McCain Foods USA is recalling Fire-Roasted 1/2" Diced Red Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted 1/2" Diced Red Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0239-2019·2018-10-31

    McCain Foods Recalls Sautéed Onion Strips Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Sautéed Julienne Onion Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed Julienne Onion Strips With Canola Caramel; Sold in 20 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0231-2019·2018-10-31

    McCain Foods Recalls Pepper Strips Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Fire-Roasted Homestyle Julienne Tri-Colored Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Homestyle Julienne Tri-Colored Pepper Strips; Sold in 20 lb. containers. Brand Name:Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·18V771000·2018-10-31

    Kia Recalls 2019 Forte Vehicles for Headlight Aiming Defect

    Kia is recalling 2019 Forte vehicles with LED headlights because they may not be aimed correctly, potentially reducing driver visibility and increasing crash risk.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0215-2019·2018-10-31

    McCain Recalls Fire Roasted Red Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Red Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Red Pepper Strips: Sold in 20 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0203-2019·2018-10-31

    Data Innovations Recalls Abbott Alinity ci-series Software Driver

    Data Innovations is recalling a software driver for Abbott Alinity ci-series instruments that fails to process quality control results, potentially delaying or causing incorrect patient treatment.

    Product
    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0200-2019·2018-10-31

    Smith+Nephew Legion AP Femoral Cutting Block Recalled for Oversized Spring

    Smith & Nephew is recalling one lot of Legion AP femoral cutting blocks, size 6, because they were manufactured with an oversized spring.

    Product
    Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0234-2019·2018-10-31

    McCain Recalls Organic Diced Onions Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Sautéed 3/8" Diced Organic Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed 3/8" Diced Organic Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0322-2019·2018-10-31

    McCain Recalls Fire-Roasted Green Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling 7,219 cases of Fire-Roasted Home-Style Green Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted Home-Style Green Pepper Strips;: Sold in 20 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0257-2019·2018-10-31

    McCain Recalls Jon-Lin Sauted Green Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Jon-Lin Sauted Green Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed Green Pepper Strips: Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0235-2019·2018-10-31

    McCain Recalls Fire Roasted Diced Green Zucchini Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Diced Green Zucchini because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Green Zucchini ; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0186-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

    Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients.

    Product
    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT REFURB, Model Number Bl70000027GERR Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits f
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0214-2019·2018-10-31

    Siemens APTIO Rack Output Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0265-2019·2018-10-31

    Custom Healthcare Systems Recalls Surgical Gowns Due to Sterility Compromise

    Custom Healthcare Systems is recalling 89 units of surgical gowns and convenience kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0260-2019·2018-10-31

    Custom Healthcare Systems Recalls Penrose Drain Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 24 units of Penrose Drain Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0278-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V RWK, Model Number Bl70000027230R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0273-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, Model Number Bl70000027100 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D an
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0213-2019·2018-10-31

    Siemens APTIO 9000 Refrigerated Storage Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO 9000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO 9000 REFRIGERATED STORAGE MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighNHTSA·18V768000·2018-10-31

    Forest River Recalls Motorhomes Due to Windshield Shade Visibility Hazard

    Forest River is recalling specific 2017-2019 motorhomes because the driver's windshield roller shade may unroll unexpectedly, blocking visibility and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE, CHARLESTON, GEORGETOWN, FR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2019·2018-10-31

    Teva Recalls Pioglitazone and Metformin Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Pioglitazone and Metformin tablets because some may lack laser drilling, potentially affecting drug release.

    Product
    PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkwa
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0206-2019·2018-10-31

    ESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE is recalling 10 MyLab Seven ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Seven, Model 6400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0253-2019·2018-10-31

    McCain Recalls Fire Roasted Yellow Pepper Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Fire Roasted Yellow Pepper Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted Yellow Pepper Strips; Sold in 20 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0228-2019·2018-10-31

    Jalapeno Poblano Onion Blend Recalled Due to Presumptive Listeria and Salmonella Test Results

    McCain Foods USA recalled its Jalapeno Poblano Onion Blend because internal testing found presumptive positive results for Listeria monocytogenes and Salmonella, though no confirmed illnesses were reported.

    Product
    Jalapeno Poblano Onion Blend; Sold in 2 lb. and 25 lb. containers. Brand Name:Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0242-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling specific lots of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0227-2019·2018-10-31

    McCain Recalls Sautéed Organic Onion Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Sautéed Organic Onion Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Saut¿ed Organic Onion Strips; Sold in 25 lb. containers. Brand Name:Jon-Lin¿ NatureSmart¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0208-2019·2018-10-31

    McCain Foods Recalls Caramelized Onion Strips Due to Listeria and Salmonella

    McCain Foods USA is recalling Caramelized Onion Strips because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Caramelized Onion Strips: Sold in 2 lb. and 25 lb. packages. Brand Name: Jon-Lin¿ NatureSmart¿; Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0218-2019·2018-10-31

    McCain Recalls Fire Roasted Diced Green Peppers Due to Pathogen Testing Issues

    McCain Foods USA is recalling Fire Roasted 1/2" Diced Green Peppers because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire Roasted 1/2" Diced Green Peppers: Sold in 25 lb. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0210-2019·2018-10-31

    McCain Recalls Fire-Roasted Portobello Mushrooms Due to Listeria and Salmonella Testing Issues

    McCain Foods USA is recalling Fire-Roasted Thin Sliced Portobello Mushrooms because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    FIRE-ROASTED THIN SLICED PORTOBELLO MUSHROOMS: Sold in 2 lb. . packages. Brand Name: Jon-Lin¿ NatureSmart¿;
    Category
    Food
    Distribution
    0 states

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