The Recall Desk

Archive

March 2019 recalls

999 recalls were announced in March 2019.

What the numbers show

Critical
264
Severe
440
High
211
Moderate
68
Low
16

Of the 999 recalls this month scored against our rubric, 26% are Critical, 44% are Severe.

901–999 of 999

  • HighFDA (Devices)·Z-0889-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2019·2019-03-06

    Organon Teknika Recalls Vitek 2 Reagent Cards Due to Seal Integrity Issues

    Organon Teknika Inc is recalling 129,321 cartons of Vitek 2 reagent cards worldwide due to compromised top seal integrity that may cause inaccurate test results.

    Product
    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0867-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera Achieva 1.5T MRI systems because ceiling speakers may be pulled by the magnetic field and fall.

    Product
    Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that could cause leaks and reduced drug delivery.

    Product
    AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2019·2019-03-06

    Philips Ingenia 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Ingenia 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V180000·2019-03-06

    Porsche Recalls 2018 Panamera Models Due to Electrical Control Unit Defect

    Porsche is recalling 2018 Panamera models because incorrect soldering on a control unit may cause intermittent system failures and impaired driveability.

    Product
    PORSCHE — PORSCHE PANAMERA TURBO SPORT TURI, PANAMERA 4S EXECUTIVE, PANAMERA TURBO S HYBRID E, PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2019·2019-03-06

    Philips Achieva 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc is recalling specific Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2019·2019-03-06

    Philips Ingenia 1.5T MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling Ingenia 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2019·2019-03-06

    Philips Achieva 1.5T MRI System Recalled Due to Falling Speaker Hazard

    Philips Medical Systems is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2019·2019-03-06

    Philips Prodiva CX MRI Systems Recalled for Ceiling Speaker Hazard

    Philips is recalling Prodiva CX MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling 19 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Fall Risk

    Philips is recalling Intera 1.5T Achieva CV Nova MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2019·2019-03-06

    Arrow AutoFuser Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0951-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International is recalling specific AutoFuser pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2019·2019-03-06

    Philips Achieva 3.0T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2019·2019-03-06

    Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard

    Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2019·2019-03-06

    Philips Ingenia 1.5T CX MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling Ingenia 1.5T CX MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2019·2019-03-06

    Philips Achieva 3.0T TX MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Achieva 3.0T TX MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2019·2019-03-06

    FDA Recalls Surgical Convenience Kits Due to Potential Sterilization Failure

    American Contract Systems, Inc. is recalling 51,152 surgical convenience kits distributed in Florida because they may not have reached complete sterilization.

    Product
    Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0900-2019·2019-03-06

    Philips MRI System Recall Due to Falling Ceiling Speaker Hazard

    Philips is recalling 11,226 MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2019·2019-03-06

    Philips Achieva MRI System Recalled for Falling Ceiling Speaker Hazard

    Philips is recalling Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2019·2019-03-06

    Elekta Recalls Monaco Radiation Treatment Planning System Software

    Elekta, Inc. is recalling 14 Monaco Radiation Treatment Planning System devices due to a software defect that may cause incorrect optimization models to be used during online plan adaptation.

    Product
    Monaco Radiation Treatment Planning (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0910-2019·2019-03-06

    Philips Ingenia 1.5T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Ingenia 1.5T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2019·2019-03-06

    Philips Intera 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2019·2019-03-06

    Philips Intera 1.5T MRI System Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because a manufacturing issue prevents them from threading properly with mating components.

    Product
    Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2019·2019-03-06

    Philips Prodiva CS MRI System Recalled for Falling Speaker Hazard

    Philips is recalling Prodiva CS MRI systems because ceiling speakers may fall due to the magnetic field.

    Product
    Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International is recalling 38 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2019·2019-03-06

    Philips Multiva MRI System Recalled for Falling Ceiling Speaker Hazard

    Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2019·2019-03-06

    Philips Intera 3.0T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Intera 3.0T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1098-2019·2019-03-06

    Aldi Bake Shop Lemon Loaf Cake Recalled for Undeclared Walnuts

    Gold Coast Bakery is recalling Aldi Bake Shop Lemon Loaf Cakes because they contain undeclared visible walnuts, a major food allergen.

    Product
    Aldi Bake Shop Lemon Loaf Cake 16 oz clear clam shell, 6 per tray (each tray includes 6 lemon loaf and 6 banana loaf) UPC 4099100018523
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0941-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks

    Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.

    Product
    AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2019·2019-03-06

    Philips Panorama 1.0T MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Panorama 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1100-2019·2019-03-06

    Nita Crisp Spelt Bread Cracker Recalled for Undeclared Wheat

    Nita Foods Inc. is recalling Nita Crisp Spelt Bread Crackers because the product contains undeclared wheat, a major food allergen.

    Product
    Nita Crisp Spelt Bread Cracker, 8- & 16-ounce bags, In paper bags with a plastic window and has a re-closable ability and safety sealed. Storage: Ambient & Dry
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0942-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling 8 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2019·2019-03-06

    Merge Eye Station Retinal Imager Recalled for Electrical Safety Defects

    Merge Healthcare is recalling 1,252 WinStation Retinal Imagers because certain configurations may produce electrical output exceeding allowable medical device limits.

    Product
    The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2019·2019-03-06

    Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks

    Arrow International Inc. is recalling 9 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.

    Product
    AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2019·2019-03-06

    Philips Multiva MRI System Recalled for Ceiling Speaker Hazard

    Philips is recalling Multiva 1.5T MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2019·2019-03-06

    Philips MRI System Recall for Falling Ceiling Speaker Hazard

    Philips is recalling Intera Achieva 1.5T Pulsar MRI systems because ceiling speakers may fall due to magnetic attraction.

    Product
    Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2019·2019-03-06

    Alcon Ophthalmic Microscope Recalled for Potential Optical Head Detachment

    Alcon is recalling LuxOr E71 and E71 Q-Vue ophthalmic microscopes because the optical head may detach from the stand due to missing thread adhesive.

    Product
    Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2019·2019-03-06

    Philips MR-OR 3.0T MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling 11,226 MR-OR 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2019·2019-03-06

    Philips Achieva XR MRI Systems Recalled for Falling Speaker Hazard

    Philips is recalling Achieva XR MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2019·2019-03-06

    Philips Achieva MRI Systems Recalled Due to Ceiling Speaker Hazard

    Philips is recalling 11,226 Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.

    Product
    Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2019·2019-03-06

    Draco Enzymatic Deep-Cleaning Pads recalled due to Pseudomonas contamination

    The FDA issued recall Z-0969-2019 for Draco Enzymatic Deep-Cleaning Pads because they were found contaminated with Pseudomonas bacteria.

    Product
    Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use.…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-1102-2019·2019-03-06

    Citrus Systems Recalls Nature's Nectar Orange Juice for Pasteurization Failure

    Citrus Systems Inc is recalling Nature's Nectar High Pulp Orange Juice because the product cannot be verified as having achieved the required 5-log reduction per 21 CFR 120.

    Product
    Nature's Nectar High Pulp Orange Juice, Never from Concentrate. Item # 420025. Pasteurized. Net 52 FL OZ (1.6 QT) 1.53L. Kosher. UPC 4 099100 056907. Keep Refrigerated. Distributed by Aldi, Inc. Batavia, IL 60510.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0936-2019·2019-03-06

    Siemens Sensis Vibe System Recalled for Software Crash Risk

    Siemens Medical Solutions is recalling one Sensis Vibe System unit due to a software error that may cause system crashes during clinical procedures.

    Product
    Sensis Vibe System, Model Number 11007642, with software version VD10B.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0938-2019·2019-03-06

    Zimmer Biomet Recalls Vanguard Knee Patella Implants Due to Labeling Mismatch

    Zimmer Biomet is recalling 90 Vanguard Knee System patella implants because a potential commingle could result in the implant size not matching the label.

    Product
    Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1097-2019·2019-03-06

    Planetary Herbals Mullein Lung Complex Recalled for Labeling Error

    Planetary Herbals is recalling Mullein Lung Complex capsules due to a labeling error regarding inactive ingredients.

    Product
    Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Proprietary Blend: Platycodon root, Ophiopagon Rhizome, Long Pepper Fruit, Black…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1054-2019·2019-03-06

    King Orchards Tart Cherry Concentrate Recalled for Incorrect Sugar Labeling

    King Orchards is recalling Montmorency Tart Cherry Concentrate because the nutrition label lists 1g of sugar per serving instead of the actual 15g.

    Product
    Montmorency Tart Cherry Concentrate 100% Juice 32-oz bottle (sold individual and 12 per case), 16-oz bottle (sold individual and 12 per case), and 1-oz packet (sold individual and per 25, 50, 100, 250, 300, and 1000)
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0933-2019·2019-03-06

    Becton Dickinson Recalls Phoenix AST-s Indicator Due to Test Aborts

    Becton Dickinson is recalling Phoenix AST-s Indicator lots because they cause increased test aborts. The products were distributed to 41 US states and 33 foreign countries.

    Product
    Phoenix AST-s Indicator, Catalog Number 246009
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-0967-2019·2019-03-06

    Cook Inc. Recalls Gastrointestinal Suture Anchor Sets Due to Retention Mechanism Issue

    Cook Inc. is recalling 797 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding the retention mechanism.

    Product
    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0959-2019·2019-03-06

    Shimadzu BRANSIST safire Digital Angiography System Software Recall

    Shimadzu Medical Systems is recalling eight BRANSIST safire digital angiography systems due to a software error that can cause abnormal termination during initial patient registration.

    Product
    BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2019·2019-03-06

    Cook Inc. Recalls Gastrointestinal Suture Anchor Sets Due to Retention Mechanism Issue

    Cook Inc. is recalling 975 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding down the retention mechanism.

    Product
    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0966-2019·2019-03-06

    Terumo Cardiovascular Procedure Kit Recalled for Undeclared Natural Rubber Latex

    Terumo Cardiovascular Systems Corporation is recalling 12 packs of Cardiovascular Procedure Kits because the presence of natural rubber latex is not declared on the label.

    Product
    Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0935-2019·2019-03-06

    Becton Dickinson Recalls Phoenix AP AST Indicator Bags Due to Test Aborts

    Becton Dickinson is recalling Phoenix AP AST Indicator Bags because certain lots cause increased test aborts. The products were distributed to 40 US states and 33 foreign countries.

    Product
    Phoenix AP AST Indicator Bag, Catalog Number 246006
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-0960-2019·2019-03-06

    Abbott Vascular Recalls PLUS 30 Priority Pack Accessory Kit Due to Expiration Error

    Abbott Vascular is recalling 26 units of the PLUS 30 Priority Pack Accessory Kit because an incorrect expiration date was entered for one lot.

    Product
    PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1101-2019·2019-03-06

    Klaire Labs Melatonin Lozenge Formula Recalled Due to Incorrect Ingredient

    ProThera, Inc. is recalling 120 bottles of Klaire Labs Melatonin Lozenge Formula because the product was filled with L-Theanine instead of melatonin.

    Product
    Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0934-2019·2019-03-06

    Becton Dickinson Recalls Phoenix AST Indicator Due to Test Aborts

    Becton Dickinson is recalling Phoenix AST Indicator lots because panels show increased test aborts. The recall covers 62,880 units distributed in the US and 33 foreign countries.

    Product
    Phoenix AST Indicator, Catalog Number 246004
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-0963-2019·2019-03-06

    BrosMed Hermes NC PTA Balloon Catheter Recalled for Labeling Error

    BrosMed Medical Co., Ltd. is recalling 400 Hermes NC PTA Balloon Dilatation Catheters because the labels display incorrect, higher-rated burst pressure information.

    Product
    Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0517-2019·2019-03-06

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Impurity Levels

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0958-2019·2019-03-06

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Packaging Instructions

    Exactech is recalling 40 Equinoxe Preserve Humeral Stems because they may have been packaged with instructions for a different knee implant.

    Product
    Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1099-2019·2019-03-06

    Prolacta Bioscience Recalls Unreleased Human Milk Caloric Fortifier Lot

    Prolacta Bioscience is recalling a specific lot of human milk caloric fortifier that was under quarantine and not released for distribution.

    Product
    Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate.…
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V169000·2019-03-05

    Jayco Recalls 2017-2019 Seismic Fifth Wheel Trailers for Brake Line Defect

    Jayco is recalling 2017-2019 Seismic fifth wheel trailers with optional hydraulic brakes because brake lines may be pinched or cut, increasing crash risk.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO SEISMIC, redundant SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V173000·2019-03-05

    Jayco Recalls 2019 Fifth Wheel Trailers Due to Awning Fuse Error

    Jayco is recalling 2019 North Point and Pinnacle fifth wheel trailers because an incorrect fuse in the awning circuit increases the risk of fire.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL PINNACLE, NORTH POINT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V175000·2019-03-05

    Entegra Esteem Motorhomes Recalled for Parking Brake Cable Defect

    Entegra is recalling 2019 Esteem motorhomes because parking brake cable ends may be too small, allowing the cable to disconnect and preventing the emergency brake from engaging.

    Product
    ENTEGRA — ENTEGRA ESTEEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V176000·2019-03-05

    Kenworth Trucks Recalled for Potential Rear Axle Oil Deficiency

    PACCAR is recalling 2020 Kenworth T680, T800, T880, W900, and W990 trucks because rear axles may lack oil, increasing crash risk.

    Product
    KENWORTH — KENWORTH T680, T800, T880, W900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V171000·2019-03-05

    2019 Western Star Trucks Recalled for Odometer Unit Labeling Error

    Daimler Trucks North America is recalling 2019 Western Star 4700 and 4900 trucks because the odometer displays miles but tracks kilometers, potentially causing driver confusion.

    Product
    WESTERN STAR — WESTERN STAR 4700, 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V170000·2019-03-05

    Thomas Built Buses Minotour Recalled for Wheelchair Lift Safety Defect

    Daimler Trucks North America is recalling 2003-2019 Thomas Built Buses Minotour school buses because the wheelchair lift can operate without the parking brake engaged, posing an injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V162000·2019-03-04

    Darley Recalls 2017-2019 Fire Trucks Due to Brake Light Wiring Defect

    W. S. Darley & Co. is recalling 2017-2019 WASP fire trucks because brake lights may illuminate without the pedal being pressed, potentially confusing other drivers.

    Product
    DARLEY — DARLEY FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V163000·2019-03-04

    LDV Command Center and Emergency Response Vehicles Recalled for Brake Light Defect

    LDV, Inc. is recalling 2017-2018 Command Center and Emergency Response vehicles because brake lights may illuminate without the pedal being pressed, potentially confusing other drivers.

    Product
    LDV, INC. — LDV, INC. COMMAND CENTER, EMERGENCY RESPONSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V165000·2019-03-04

    KZRV Recalls 2019 RVs Due to Cooktop Flame Inversion Risk

    KZRV is recalling 2019 Sportsmen, Escape, and Sonic Lite trailers because the cooktop flame may invert, increasing burn risk.

    Product
    KZRV — KZRV SPORTSMEN, ESCAPE, SONIC LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·024-2019·2019-03-02

    Washington Beef Recalls Ground Beef Chubs Due to Foreign Matter Contamination

    Washington Beef, LLC is recalling approximately 30,260 pounds of ground beef chubs that may contain hard plastic or metal. The products were shipped nationwide and no adverse reactions have been reported.

    Product
    Washington Beef, LLC — Washington Beef, LLC Recalls Ground Beef Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V157000·2019-03-01

    BMW Recalls C600 and C650 Scooters for Brake Hose Leak Risk

    BMW is recalling 2013-2019 C600 and C650 scooters because the front brake hose may crack and leak, increasing crash risk.

    Product
    BMW — BMW C650 GT MAXI-SCOOTER, C650 SPORT MAXI-SCOOTER, C600 SPORT MAXI-SCOOTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V153000·2019-03-01

    Goshen Impulse Shuttle Buses Recalled for Seat Lock Defect

    Eldorado National-Kansas is recalling 2015-2016 Goshen Impulse shuttle buses because foldaway seat cushions may not stay locked during a crash.

    Product
    GOSHEN — GOSHEN IMPULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E018000·2019-03-01

    DiamondBack Recalls HD and SE Truck Bed Covers for Separation Risk

    DiamondBack is recalling HD and SE three-panel hard tonneau truck bed covers because the front panel may lift and separate while driving, creating a road hazard.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V332000·2019-03-01

    Prime-Time Recalls 2016-2018 Ram ProMaster and Ford Transit Vehicles

    Prime-Time Specialty Vehicles is recalling 2016-2018 Ram ProMaster and Ford Transit vans with Freedman GO-ES Foldaway Seats because the seat cushions may not stay locked during a crash.

    Product
    RAM — RAM, FORD PROMASTER, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V152000·2019-03-01

    Terex Advance Recalls 2018-2019 Concrete Mixer Trucks for Brake Defect

    Terex Advance is recalling 2018-2019 Front Discharge Concrete Mixer Trucks because cracked drive pins in the brake calipers may fracture, causing loss of vehicle control.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE CONCRETE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V156000·2019-03-01

    Indian Recalls 2019 Scout Motorcycles Due to Brake Performance Issues

    Indian Motorcycle is recalling 2019 Scout, Scout Bobber, and Scout Sixty models because trapped air in the brake system may reduce performance and increase crash risk.

    Product
    INDIAN — INDIAN SCOUT, SCOUT BOBBER, SCOUT SIXTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V155000·2019-03-01

    Maintainer Recalls 2017-2018 Rescue Vehicles Due to Brake Light Wiring Issue

    Maintainer is recalling 2017-2018 MCB Custom Bodies Responders/Rescue Walkaround vehicles because Whelen brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    MAINTAINER — MAINTAINER RESCUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V160000·2019-03-01

    Supreme Classic American Trolley Recall for Wheelchair Lift Defect

    Supreme is recalling 2014-2016 Classic American Trolley vehicles because a wheelchair lift cam may fail, causing the platform to rise too high and increasing injury risk.

    Product
    SUPREME — SUPREME CLASSIC AMERICAN TROLLEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V159000·2019-03-01

    Marion Fire and Emergency Apparatus Brake Light Recall

    Marion is recalling 2017-2018 Fire and Emergency Apparatus vehicles because Whelen brake lights may illuminate without the brake pedal being pressed.

    Product
    MARION — MARION FIRE AND EMERGENCY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V161000·2019-03-01

    SVI Trucks Recalls 2018 Emergency Vehicles for Brake Light Defect

    SVI Trucks is recalling 2018 emergency vehicles because Whelen brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    SVI TRUCKS — SVI TRUCKS SVI TRUCKS, HEAVY RESCUE, FIRE ENGINE, HAZ-MAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V158000·2019-03-01

    Ameritrans Recalls One 2016 E225 Bus Due to Wheelchair Lift Defect

    Ameritrans is recalling one 2016 E225 bus because a wheelchair lift component may fail, causing the platform to rise too high and increasing injury risk.

    Product
    AMERITRANS — AMERITRANS E225
    Category
    Vehicle
    Distribution
    Distributed nationwide

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