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.

101–200 of 865

  • 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 (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 (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-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 (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-0204-2019·2018-10-31

    McCain Foods Recalls Fire Roasted Diced Red Peppers Due to Listeria and Salmonella

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

    Product
    Fire Roasted 1/2" Diced Red Peppers; Sold in 2 lb. and 25 lb. containers Brand name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0221-2019·2018-10-31

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

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

    Product
    Fire Roasted 1/4" Diced Red Peppers: Sold in 25 lb. Brand Name: Jon-Lin¿
    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 (Devices)·Z-0209-2019·2018-10-31

    Siemens APTIO Input/Output Modules Recalled for Missing Pacemaker Warning Label

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

    Product
    APTIO INPUT/OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 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-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 (Food)·F-0326-2019·2018-10-31

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

    McCain Foods USA is recalling Fire-Roasted Red Jalapeno Slices because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Fire-Roasted Red Jalapeno Slices; Sold in 2 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0205-2019·2018-10-31

    ESAOTE MyLab Gamma Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE S.P.A. is recalling 10 MyLab Gamma, Model 7410 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Gamma, Model 7410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (Devices)·Z-0201-2019·2018-10-31

    GE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk

    GE Medical Systems is recalling 356 Discovery 3.0T MR750 MRI scanners because a specific coil can overheat in Mode 2, posing a risk of serious patient thermal injury.

    Product
    GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
    Category
    Medical Device
    Distribution
    26 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 (Devices)·Z-0271-2019·2018-10-31

    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, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 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 and 3
    Category
    Medical Device
    Distribution
    45 states
  • HighNHTSA·18V767000·2018-10-31

    Keystone Recalls 2019 Crossroads Cruiser Trailers Due to Gas Leak Risk

    Keystone RV Company is recalling 2019 Crossroads Cruiser recreational trailers because the water heater exhaust may allow carbon monoxide or propane gas to enter the living quarters.

    Product
    CROSSROADS — CROSSROADS CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (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 (Food)·F-0325-2019·2018-10-31

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

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

    Product
    Fire Roasted 1/2" Diced Eggplant;: Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0197-2019·2018-10-31

    Shimadzu TRINIAS Digital Angiographic System Recalled for C-Arm Movement Issue

    Shimadzu is recalling one TRINIAS Digital Angiographic System in Louisiana due to a software issue that may cause the C-arm to move unexpectedly, posing a risk of contact with patients or staff.

    Product
    TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Food)·F-0226-2019·2018-10-31

    McCain Recalls Fire-Roasted Bell Peppers and Onions Due to Listeria and Salmonella

    McCain Foods USA is recalling Trader Joe's Fire-Roasted Bell Peppers and Onions because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.

    Product
    Fire-Roasted Bell Peppers and Onions Sold in 14 oz. package. Brand Name:Trader Joe's none
    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-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-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-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-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-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 (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 (Food)·F-0246-2019·2018-10-31

    McCain Foods Recalls Caramelized Mushroom Slices Due to Listeria and Salmonella

    McCain Foods USA is recalling 244 cases of Jon-Lin Caramelized Mushroom Slices because the product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.

    Product
    Caramelized Mushroom Slices; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0199-2019·2018-10-31

    Canon MRI Systems Recall Due to SAR Display Error

    Canon Medical System is recalling 252 MRI systems because the displayed SAR value may be lower than the actual value, potentially exceeding safety limits.

    Product
    Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
    Category
    Medical Device
    Distribution
    41 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-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 (Devices)·Z-0267-2019·2018-10-31

    CHS Custom Convenience Kits Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
    Category
    Medical Device
    Distribution
    9 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-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-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-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-0236-2019·2018-10-31

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

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

    Product
    Fire-Roasted Cauliflower Florets ; 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
  • ModerateFDA (Devices)·Z-0275-2019·2018-10-31

    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 Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 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
  • ModerateFDA (Drugs)·D-0084-2019·2018-10-31

    Valeant Recalls Cortaid Intensive Therapy Cooling Spray Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling specific lots of Cortaid Intensive Therapy Cooling Spray due to cGMP deviations identified after a supplier recall for microbial contamination.

    Product
    Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
    Category
    Drug
    Distribution
    0 states
  • ModerateCPSC·19026·2018-10-31

    Fantasia Accessories Recalls Slap Bracelets Due to Laceration Hazard

    Fantasia Accessories is recalling about 22,500 children's slap bracelets sold at Target because the metal band can pierce the fabric cover, posing a laceration hazard.

    Product
    Slap bracelets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0072-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls HEB Organics Hummus Due to Foreign Material

    Cedar's Mediterranean Foods is recalling HEB Organics Traditional Hummus because the product contains foreign material. The recall affects 37,521 units distributed in Texas.

    Product
    HEB Organics TRADITIONAL HUMMUS, NET WT. 8 OZ (227g), 4 pack, UPC: 0 41220 79565 9, Keep Refrigerated contains individual units, NET WT. 2 OZ (56g).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0237-2019·2018-10-31

    Micro-Tech Recalls Single-Use Biopsy Forceps Due to Incorrect Product Contents

    Micro-Tech (Nanjing) Co., Ltd. is recalling 1,360 units of Single-Use Biopsy Forceps because the boxes contained Grasping Forceps instead of the labeled product.

    Product
    Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0279-2019·2018-10-31

    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, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER 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 2
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0230-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 8 BACT/ALERT VIRTUO systems because firmware version R2.0 allows calibration standards to be moved, potentially causing anomalies if not returned to designated locations.

    Product
    BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 440 Micro Surgery Handpiece SGA units because reprocessing instructions have been updated. Previous operation manuals must be replaced.

    Product
    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0220-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling SGS-E2G surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0223-2019·2018-10-31

    Nakanishi SGS-ES Micro Surgery Handpiece Recall for Updated Instructions

    Nakanishi Inc. is recalling 2,419 SGS-ES Micro Surgery Handpieces to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0096-2019·2018-10-31

    Teva Recalls Paliperidone Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals is recalling 27,816 bottles of Paliperidone Extended Release Tablets 3 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), 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
  • ModerateFDA (Drugs)·D-0092-2019·2018-10-31

    Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 2,712 bottles of Fluocinolone Acetonide Topical Solution because stability testing showed total impurities exceeded specifications.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0083-2019·2018-10-31

    Lannett Recalls Hydroxyzine Hydrochloride Syrup Due to Impurities

    Lannett Company is recalling 8,324 bottles of Hydroxyzine Hydrochloride Syrup because cleaning procedures caused out-of-specification results for unknown impurities.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0281-2019·2018-10-31

    Upsher Smith Recalls Bumetanide Tablets for Unspecified Degradation Product

    Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.

    Product
    BUMETANIDE — BUMETANIDE (BUMETANIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2019·2018-10-31

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 135 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System because one energy platform is not compatible with the device.

    Product
    VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0071-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls HEB Select Ingredients Roasted Garlic Hummus

    Cedar's Mediterranean Foods is recalling HEB Select Ingredients Roasted Garlic Hummus due to the presence of foreign material.

    Product
    HEB Select Ingredients ROASTED GARLIC HUMMUS PREMIUM QUALITY NET WT 8 OZ (227g) UPC 0 41220 33495 7 and NET WT. 16 OZ (1 LB) 454g), UPC 0 41220 67250 9
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0129-2019·2018-10-31

    Teva Recalls Metoprolol Succinate Extended Release Tablets Due to Dissolution Failure

    Teva Pharmaceuticals USA is recalling 53,451 bottles of Metoprolol Succinate Extended Release Tablets 50 mg because routine stability testing revealed out-of-specification dissolution results.

    Product
    Metoprolol Succinate Extended Release Tablets, USP 50 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 62037-831-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2019·2018-10-31

    Stryker Altrix Temperature Management System Recalled for Alarm Faults

    Stryker is recalling 389 Altrix Precision Temperature Management Systems due to frequent alarms and mechanical interference faults.

    Product
    Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 516 BACT/ALERT VIRTUO systems with R2.0 firmware because a service feature may leave calibration standards in incorrect locations, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0101-2019·2018-10-31

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

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0226-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,878 Micro Surgery Handpiece SGA units to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0221-2019·2018-10-31

    Nakanishi SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 18 SGA-E surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave sterilization parameters.

    Product
    Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0057-2019·2018-10-31

    Lutosa Plain Mashed Potato Recall for Potential Foreign Objects

    Lutosa S.A. is recalling specific lots of Plain Mashed Potato due to potential plastic and rubber pieces.

    Product
    Lutosa Foodservice Quality Plain Mashed Produced in Belgium 2.5 kg/5.5 lb
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0231-2019·2018-10-31

    Ecolab recalls sterile instrument arm drapes due to potential seal defects

    Ecolab is recalling specific lots of sterile instrument arm drapes for the Da Vinci Si system because seal wrinkles may compromise sterility.

    Product
    Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap vari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2019·2018-10-31

    Synthes 3.0mm Headless Compression Screws Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 20 units of 3.0mm Headless Compression Screws because the product inside the package does not match the label.

    Product
    3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0239-2019·2018-10-31

    Philips DigitalDiagnost Software Recall for X-ray System Stitching Defects

    Philips is recalling DigitalDiagnost software for stationary X-ray systems due to intermittent stitching interruptions and incorrect baseline data on the system CD.

    Product
    Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0070-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls Hummus Due to Foreign Material

    Cedar's Mediterranean Foods is recalling Central Market All Natural Traditional Hummus because the product contains foreign material. The recall affects 37,521 units distributed in Texas.

    Product
    Central Market All Natural Traditional Hummus TOPPED WITH SESAME SEEDS, NET WT 10 OZ (284g).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0130-2019·2018-10-31

    RXQ Compounding Recalls Subpotent Lidocaine and Epinephrine Injection Vials

    RXQ Compounding LLC is recalling 395 vials of Lidocaine 1% + Epinephrine 1:100,000 injection solution because testing revealed the product was subpotent.

    Product
    Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0196-2019·2018-10-31

    Medacta MiniMAX Cementless Hip Stem Recalled for Packaging Breach

    Medacta USA Inc. is recalling 837 units of MiniMAX Cementless Anatomical Stems because complaint monitoring identified a trend of packaging breaches.

    Product
    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0233-2019·2018-10-31

    Ecolab Recalls Disposable Accessory Kits for Da Vinci Robotic System

    Ecolab Inc is recalling specific lots of Disposable Accessory Kits, 3-Arm, due to potential pouch seal defects that could compromise sterility.

    Product
    Disposable Accessory Kit, 3-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
  • ModerateFDA (Food)·F-0069-2019·2018-10-31

    Cedar's Mediterranean Foods Recalls Hummus Due to Foreign Material

    Cedar's Mediterranean Foods is recalling Central Market All Natural Mediterranean Hummus because it contains foreign material. The product was distributed directly to Texas.

    Product
    Central Market All Natural Mediterranean Hummus, NET WT 10 OZ (284g), UPC: 0 41220 91513 2
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0219-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 12 SGS-E surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0089-2019·2018-10-31

    Westlab Pharmacy Recalls Alprostadil Injectable Vials Due to Incorrect Formulation

    Westlab Pharmacy is recalling 80 vials of Alprostadil 500 mcg/mL Injectable due to an incorrect product formulation. The recall covers nationwide distribution.

    Product
    Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2019·2018-10-31

    Valeant Recalls Cortaid Maximum Strength Cream Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling specific lots of Cortaid Maximum Strength Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.

    Product
    Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0100-2019·2018-10-31

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

    Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0222-2019·2018-10-31

    Nakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling six SGA-E2G surgical handpieces because reprocessing instructions have been updated to include manual cleaning and specific autoclave parameters.

    Product
    Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0229-2019·2018-10-31

    bioMerieux Recalls BACT/ALERT VIRTUO Systems Due to Firmware Calibration Issue

    bioMerieux is recalling 151 BACT/ALERT VIRTUO systems with R2.0 firmware because a software feature may allow calibration standards to be left in incorrect positions, potentially causing anomalies.

    Product
    BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0224-2019·2018-10-31

    Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0086-2019·2018-10-31

    Valeant Recalls Cortaid 12-Hour Anti-itch Cream Due to cGMP Deviations

    Valeant Pharmaceuticals is recalling 5,016 tubes of Cortaid 12-Hour Advanced Anti-itch Cream due to current Good Manufacturing Practice (cGMP) deviations identified during a supplier review.

    Product
    Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0087-2019·2018-10-31

    Lupin Recalls Testosterone Topical Solution Due to Defective Pump

    Lupin Pharmaceuticals is recalling 6,752 bottles of Testosterone Topical Solution because the pump mechanism is not working.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0270-2019·2018-10-31

    Ameditech Recalls Accutest Drug Test Cups Missing Adulteration Strip

    Ameditech Inc is recalling Accutest Drug Test Cup 5+3 units because they were released without the required adulteration strip.

    Product
    Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the pres
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-0060-2019·2018-10-31

    Victoria Taylor's New Orleans Seasoning Recalled for Incorrect Labeling

    Victoria Gourmet, Inc. is recalling 17 jars of Victoria Taylor's Seasonings - New Orleans due to incorrect product labeling. No illnesses or injuries have been reported.

    Product
    Victoria Taylor's Seasonings - New Orleans - 5.0 oz. UPC: 666227015090, packaged in a glass jar with lid
    Category
    Food
    Distribution
    17 states
  • LowFDA (Food)·F-0059-2019·2018-10-31

    Victoria Taylor's Seasonings Blackening Rub Recalled for Incorrect Labeling

    Victoria Gourmet, Inc. is recalling 21 jars of Victoria Taylor's Seasonings Blackening Rub because the product labeling is incorrect.

    Product
    Victoria Taylor's Seasonings - Blackening Rub, 6.4 oz., UPC: 666227015274, packaged in a glass jar with a lid
    Category
    Food
    Distribution
    17 states
  • LowFDA (Drugs)·D-0239-2019·2018-10-31

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate

    Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution due to the presence of precipitate. The recall covers nationwide distribution.

    Product
    Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V762000·2018-10-30

    Altec Recalls 2009 Aerial Devices Due to Riser Assembly Cracking Risk

    Altec Industries is recalling 2009 LSS 60 and LSS 70 Elevator Aerial devices because the elevator riser assembly may crack and fail, increasing the risk of injury or death.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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