The Recall Desk

Archive

September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical
19
Severe
188
High
305
Moderate
102
Low
19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

Which agencies issued them

301–400 of 633

  • HighFDA (Devices)·Z-3024-2018·2018-09-19

    Intuitive Surgical Recalls da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors

    Intuitive Surgical is recalling 23,064 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors because cracks in the extension tube may cause plastic fragments to fall into patients.

    Product
    da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1977-2018·2018-09-19

    Air Stream Corp. Recalls Brussel Sprouts Due to Listeria Risk

    Air Stream Corp. is recalling Brussel Sprouts because they may be contaminated with Listeria monocytogenes. The product was distributed in several Northeastern and Mid-Atlantic states.

    Product
    Brussel Sprouts
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3165-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3092-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3157-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3164-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3143-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3047-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3085-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3149-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3160-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm, Item Number: 814611420
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3023-2018·2018-09-19

    NordicNeuroLab Recalls fMRI LCD Monitor Power Supplies Due to Magnet Bore Risk

    NordicNeuroLab AS is recalling 163 LCD monitor power supplies for fMRI systems because they were reported to be dragged into the magnet bore.

    Product
    fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3102-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3072-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm, Item Number: 814313360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3021-2018·2018-09-19

    Cardiovascular Systems Recalls Orbital Atherectomy Saline Infusion Pumps

    Cardiovascular Systems Inc is recalling 18 Orbital Atherectomy System Saline Infusion Pumps because they may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication indepen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3147-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm, Item Number: 814609280
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3100-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Malfunction

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3064-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3062-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm, Item Number: 814311400
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3105-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 400 mm, Item Number: 814413400
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3110-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 280 mm, Item Number: 814509280
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3089-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 260 mm, Item Number: 814411260
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3051-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3126-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3050-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3111-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3025-2018·2018-09-19

    Intuitive Surgical Recalls da Vinci EndoWrist Scissors Due to Cracking Risk

    Intuitive Surgical is recalling 42,274 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors because cracks may form in the extension tube, potentially causing fragments to fall into patients.

    Product
    da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3040-2018·2018-09-19

    SPS Sterilization Recalls Boston Scientific Wallstent RP Endoprosthesis Due to Labeling Error

    SPS Sterilization, Inc. is recalling three Boston Scientific Wallstent RP Endoprosthesis tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3019-2018·2018-09-19

    Remel Thioglycollate Medium Recalled for Performance Testing Failures

    Remel Inc is recalling Remel Thioglycollate Medium (Ref 05152) because products intermittently failed performance testing during stability studies.

    Product
    remel THIOGLYCOLLATE MEDIUM, REF 05152
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3035-2018·2018-09-19

    SPS Sterilization Recalls Boston Scientific Wallstent Due to Expiration Date Error

    SPS Sterilization is recalling two Boston Scientific Wallstent devices because the expiration date on the label exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2993-2018·2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Plus Reagents Due to Quality Control Failures

    Diagnostica Stago is recalling 24,043 kits of STA N¿oplastine¿ CI Plus reagents because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3032-2018·2018-09-19

    SPS Sterilization Recalls Edwards Femoral Venous Cannula Due to Shelf Life Error

    SPS Sterilization is recalling one unit of an Edwards Lifesciences Femoral Venous Cannula because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3018-2018·2018-09-19

    Remel Thioglycollate Medium Recalled for Performance Testing Failures

    Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies.

    Product
    remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3038-2018·2018-09-19

    SPS Sterilization Recalls Resterilized Boston Scientific Wallstent Enteral Endoprosthesis

    SPS Sterilization, Inc. is recalling two units of resterilized Boston Scientific Wallstent Enteral Endoprosthesis because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2994-2018·2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Reagents Due to Quality Control Issues

    Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1962-2018·2018-09-19

    Dewey's Bakery Recalls Triple Chocolate Brownie Cookies Due to Mold

    Dewey's Bakery is recalling 33,473 bags of Triple Chocolate Brownie Cookies after a customer reported finding mold in the product.

    Product
    Dewey's BAKERY Soft Baked TRIPLE CHOCOLATE BROWNIE COOKIES NET WT. 6 OZ paper bag Dewey's BAKERY WINSTON-SALEM, NC 27103 (877) 339-3974 UPC 7 63027 21022 6
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-3037-2018·2018-09-19

    Recall of Boston Scientific Tracheobronchial Stents Due to Sterilization Labeling Error

    SPS Sterilization, Inc. is recalling two Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stents because the expiration date on the labeling exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3030-2018·2018-09-19

    SPS Sterilization Recalls Edwards Venous Drainage Cannulas Due to Labeling Error

    SPS Sterilization is recalling five units of Edwards Lifesciences venous drainage cannulas because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3034-2018·2018-09-19

    SPS Sterilization Recalls Resterilized Edwards Arterial Perfusion Cannula

    SPS Sterilization is recalling one resterilized Edwards Lifesciences Optisite Arterial Perfusion Cannula because its expiration date exceeds the validated shelf life.

    Product
    Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-1963-2018·2018-09-19

    Califia Farms Mocha Cold Brew Coffee Recalled for Cleaning Chemical Contamination

    Califia Farms is recalling 48 fl. oz. Mocha Cold Brew Coffee with Almond Milk due to a process deviation that may have introduced cleaning chemicals into the product.

    Product
    Califia Farms 100% Arabica Coffee; Mocha Cold Brew Coffee with Almond Milk 48 fl. oz. plastic bottle. Dairy Free UPC: 852909003503 - USA 813636020584 (Canada) Distributed by Califia Farms, LLC, Los Angeles, CA
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3042-2018·2018-09-19

    LeMaitre AnastoClip GC Closure System Recalled for Incorrect Instructions

    LeMaitre Vascular is recalling AnastoClip GC Closure Systems because the included instructions listed uses not cleared by the FDA.

    Product
    AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-3028-2018·2018-09-19

    SPS Sterilization Recalls Edwards Lifesciences Aortic Cannula Due to Labeling Error

    SPS Sterilization is recalling 6 units of Edwards Lifesciences EZ Glide Aortic Cannulas because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3026-2018·2018-09-19

    Vascular Technology Recalls 10 Mislabeled 8 MHz Surgical Doppler Transceivers

    Vascular Technology, Inc. is recalling 10 surgical Doppler transceivers that may be mislabeled as 20 MHz units instead of 8 MHz units.

    Product
    VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3017-2018·2018-09-19

    Remel Thioglycollate Medium Recalled for Performance Testing Failures

    Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies with anaerobic microorganisms.

    Product
    remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3022-2018·2018-09-19

    ev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories

    Micro Therapeutics is recalling 67 units of the ev3 TurboHawk Peripheral Plaque Excision System because packaged accessories are incompatible with the catheter, potentially preventing the removal of excised material.

    Product
    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-3039-2018·2018-09-19

    SPS Sterilization Recalls Resterilized Boston Scientific Wallstent RP Endoprosthesis

    SPS Sterilization is recalling two units of resterilized Boston Scientific Wallstent RP Endoprosthesis because the labeling expiration date exceeds the validated shelf life.

    Product
    Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3036-2018·2018-09-19

    SPS Sterilization Recalls Boston Scientific Wallstent Tracheobronchial Stents

    SPS Sterilization is recalling two Boston Scientific Wallstent tracheobronchial stents because the expiration date on the labeling exceeds the validated shelf life of the sterilization process.

    Product
    Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L, resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3031-2018·2018-09-19

    SPS Sterilization Recalls Avid Venous Drainage Cannulas Due to Shelf Life Labeling

    SPS Sterilization is recalling 5 units of Avid Dual Stage Venous Drainage Cannulas because the expiration date on the label exceeds the validated shelf life.

    Product
    Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Drugs)·D-1185-2018·2018-09-19

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets because they contain a known impurity at levels exceeding specifications.

    Product
    Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3044-2018·2018-09-19

    Ortho-Clinical VITROS Chloride Slides Recalled for Interference Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1184-2018·2018-09-19

    Pfizer Recalls Argatroban Injection Vials Due to Stability Testing Failures

    Pfizer is recalling 1,580 vials of Argatroban Injection because stability testing results were out of specification at the 18-month time point.

    Product
    Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1187-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3043-2018·2018-09-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1186-2018·2018-09-19

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·18V640000·2018-09-18

    Forest River Recalls Buses with Defective Wheelchair Lifts

    Forest River is recalling specific 2012-2018 buses because a wheelchair lift component may fail, allowing the platform to rise too high and increasing injury risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, ELKHART, GLAVAL BUS ALLSTAR XL MVP, ALLSTAR, SENATOR II, STARLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V642000·2018-09-17

    Heil Recalls 2014-2016 Garbage Trucks Due to Cracking Hydraulic Brackets

    Heil Environmental is recalling 2014-2016 garbage trucks because hydraulic oil tank brackets may crack, causing oil leaks that increase crash risk.

    Product
    HEIL — HEIL FRONT END LOADER GARBAGE, SIDE LOADER GARBAGE TRUCK, ROLLOFF BODY/HOIST, REAR LOADER GARBAGE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V639000·2018-09-17

    Audi Recalls 2017-2018 R8 Vehicles Due to Transmission Fluid Leak Fire Risk

    Volkswagen Group of America is recalling 2017-2018 Audi R8 Spyder and Coupe vehicles because transmission fluid may leak from the gearbox ventilation hose, creating a fire risk if it contacts hot engine parts.

    Product
    AUDI — AUDI R8 SPYDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V636000·2018-09-14

    Alfa Romeo Giulia and Stelvio Recalled for Engine Fire Risk

    Chrysler is recalling 2017-2018 Alfa Romeo Giulia and 2018 Stelvio vehicles because engine misfires may overheat the catalytic converter, potentially causing a fire or engine stall.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA, STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V633000·2018-09-14

    Cruiser RV Recalls 2019 Travel Trailers Due to Axle Bearing Defect

    Cruiser RV is recalling 2019 travel trailers because missing inner bearing races may cause hub failure and increase crash risk.

    Product
    CRUISER RV — CRUISER RV FUN FINDER EXTREME LITE, SHADOW CRUISER ULTRA LITE, RADIANCE ULTRA LITE, MPG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V638000·2018-09-14

    Trail King Recalls 2016-2018 Trailers Due to Cracking Cross Members

    Trail King is recalling 2016-2018 ACS and AACS trailers because aluminum cross members may crack, potentially causing the suspension to loosen and increasing crash risk.

    Product
    TRAIL KING — TRAIL KING ACS, AACS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V635000·2018-09-14

    Alfa Romeo Stelvio Recall: Engine Cooling Hose Defect

    Chrysler is recalling 2018-2019 Alfa Romeo Stelvio Quadrifoglio vehicles because an engine cooling hose may leak coolant, causing overheating and stalling.

    Product
    ALFA ROMEO — ALFA ROMEO STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V621000·2018-09-14

    Mitsubishi Recalls Outlander Models Due to Safety System Software Defect

    Mitsubishi is recalling 2017-2018 Outlander, Outlander Sport, Eclipse Cross, and Outlander PHEV vehicles because incorrect software may prevent safety systems like automatic emergency braking from functioning.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER SPORT, ECLIPSE CROSS, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V620000·2018-09-14

    Mitsubishi Recalls Outlander and Eclipse Cross Models for Braking Software Defect

    Mitsubishi is recalling certain 2017-2019 Outlander, Outlander Sport, Eclipse Cross, and Outlander PHEV vehicles because faulty software may cause the Forward Collision Mitigation system to brake for too long, increasing the risk of a rear-end collision.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER SPORT, ECLIPSE CROSS, OUTLANDER PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V632000·2018-09-14

    Bentley Recalls 2018 Mulsanne and Bentayga for Rearview Camera Issues

    Bentley is recalling 2018 Mulsanne and Bentayga vehicles because the rearview camera display may be obstructed or delayed, increasing crash risk when reversing.

    Product
    BENTLEY — BENTLEY BENTAYGA, MULSANNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V628000·2018-09-13

    Forest River Recalls 2019 East to West Travel Trailers Due to Axle Issue

    Forest River is recalling 2019 East to West travel trailers because incorrect axle shackles may allow tires to contact the wheel well, risking tire failure and loss of control.

    Product
    FOREST RIVER — FOREST RIVER EAST TO WEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V630000·2018-09-13

    Honda Recalls 2018 CRF250L Motorcycles Due to Wiring Harness Defect

    Honda is recalling 2018 CRF250L motorcycles because an improperly installed wiring harness may damage safety components like lights and the horn, increasing crash risk.

    Product
    HONDA — HONDA CRF250L
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V624000·2018-09-13

    Forest River Recalls 2019 Travel Trailers Due to Axle Bearing Defect

    Forest River is recalling 2019 travel trailers because missing inner bearing races may cause hub overheating or separation, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN XLR, VIBE, SIERRA, SHASTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V623000·2018-09-13

    Forest River Berkshire Motorhomes Recalled for Door Latch Defect

    Forest River is recalling 2019 Berkshire motorhomes because improperly adjusted door latch rods may allow the entry door to open while the vehicle is moving.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V622000·2018-09-13

    KME Fire Trucks Recalled for Brake Light Wiring Defect

    KME is recalling 111 fire trucks because brake lights may illuminate without the pedal being pressed, potentially confusing other drivers.

    Product
    KME — KME COMMERCIAL PUMPER, COMMERCIAL TANKER, COMMERCIAL WILDLAND, PREDATOR PANTHER TANKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V625000·2018-09-13

    Land Rover Recalls 2018 Models for Silent Automatic Emergency Braking Failure

    Jaguar Land Rover is recalling 2018 Discovery, Range Rover, and Range Rover Sport vehicles because the Automatic Emergency Braking system may disable without warning, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER DISCOVERY, RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V626000·2018-09-13

    Subaru Recalls 2010-2014 Legacy and Outback for Parking Brake Defect

    Subaru is recalling 2010-2014 Legacy and Outback vehicles with manual transmissions because the electronic parking brake may fail to engage, increasing the risk of a crash.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·080-2018·2018-09-13

    Bob Evans Pork Sausage Links Recalled for Plastic Contamination

    Bob Evans Farms is recalling pork sausage links due to possible clear hard plastic contamination. No illnesses have been reported.

    Product
    BEF Foods, Inc. — Bob Evans Farms Inc. Recalls Pork Sausage Link Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·079-2018·2018-09-12

    Roya Foods Recalls Raw Halal Manti Beef Dumplings Produced Without Inspection

    Roya Foods is recalling approximately 438 pounds of raw Halal Manti Beef Dumplings because they were produced without federal inspection. No adverse reactions have been reported.

    Product
    Roya Foods, LLC Recalls Halal Manti Beef Dumpling Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1177-2018·2018-09-12

    AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

    AvKARE is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2962-2018·2018-09-12

    Bayer Medical Care Recalls Overhead Counterpoise Systems Due to Structural Risk

    Bayer Medical Care is recalling four Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·18V617000·2018-09-12

    Altec Recalls 2018 Cranes, Derricks, and Aerial Devices Due to Fastener Defect

    Altec Industries is recalling 2018 cranes, digger derricks, and aerial devices because overtightened fasteners may break, potentially causing the platform to separate from the vehicle.

    Product
    ALTEC — ALTEC DIGGER DERRICK, CRANE, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V616000·2018-09-12

    Highland Ridge RV Recalls 2019 Travel Trailers Due to Axle Bearing Defect

    Highland Ridge RV is recalling 2019 Open Range and Mesa Ridge travel trailers because missing inner bearing races may cause hub failure and increase crash risk.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT OPEN RANGE ULTRA LITE, OPEN RANGE LITE, MESA RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1946-2018·2018-09-12

    Fresh Express Recalls Chopped Romaine Due to Cyclospora Test Result

    Fresh Express is recalling 482 cases of Chopped Romaine 1 lb after a test detected the Cyclospora organism. The product was distributed in 15 U.S. states.

    Product
    Fresh Express Chopped Romaine 1 lb
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-1176-2018·2018-09-12

    AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

    AvKARE is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2980-2018·2018-09-12

    Medline Recalls LASER CDS Surgical Packs with Non-Sterile Applicators

    Medline Industries is recalling 144 LASER CDS surgical kits because specific ChloraPrep applicators were not sterilized. The non-sterile components were inadvertently released to California and New Mexico.

    Product
    LASER CDS
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1173-2018·2018-09-12

    AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

    AvKARE is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2018·2018-09-12

    AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

    AvKARE is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2018·2018-09-12

    AvKARE Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

    AvKARE is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2990-2018·2018-09-12

    GE Vivid E7 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling Vivid E7 ultrasound systems because the power cord may break and expose electrical conductors, creating a risk of electric shock.

    Product
    GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2960-2018·2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling two Overhead Counterpoise Systems because overtightened bolts may compromise structural integrity, posing a risk of injury.

    Product
    Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1172-2018·2018-09-12

    McKesson Recalls Megestrol Acetate Oral Suspension Due to Supra-Potent Drug

    McKesson is recalling 1,531 cartons of Megestrol Acetate Oral Suspension because the drug is supra-potent. The recall is voluntary and nationwide.

    Product
    Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V618000·2018-09-12

    Jayco Recalls 2019 Travel Trailers Due to Missing Axle Bearing Races

    Jayco is recalling 2019 White Hawk, Jay Flight, and Jay Flight SLX travel trailers because missing inner bearing races may cause hub overheating and axle separation.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX, JAY FLIGHT, WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide

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