Archive
622 recalls were announced in April 2018.
Of the 622 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.
Which agencies issued them
Supreme Bakery LLC is recalling 50 loaves of Moskovski Batton bread in Massachusetts due to undeclared milk and soy ingredients.
Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.
Tamarack Inc. is recalling Eclipse Kratom Premium Maeng Da capsules and bottles because they may be contaminated with Salmonella.
GE Healthcare is recalling 1,742 units of the Monica Novii Wireless Patch System because incorrectly reconnected cables may cause fetal and maternal heart rate signals to be displayed swapped.
C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were caught in the sterile barrier seal or cut.
Magellan Diagnostics is recalling 79 LeadCare Plus Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.
C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.
Life Technologies is recalling Oncomine Dx Target Test user guides and assay definition files because they may report erroneous results when used off-label for non-NSCLC samples.
Invivo Corporation is recalling DynaCAD software versions 3.4 and 3.5 because pharmacokinetic and ADC maps may display incorrectly on remote clients, potentially leading to underestimated values.
Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.
Dynavox Systems LLC is recalling 307 T15 Speech Generating Devices because the integral battery may out-gas and swell after long periods of disuse, potentially causing the device case to separate.
Seiler Instruments is recalling Alpha Air 6 ENT Microscopes because they may tip over if attachments are extended and the device is moved improperly.
C.R. Bard is recalling specific lots of HydroSil Gripper Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.
Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl because the product failed to meet stability specifications.
Aesculap Implant Systems LLC is recalling 270 DS Titanium Ligation Clip Appliers to update instructions for use, adding contraindications for living donor nephrectomies.
GE Healthcare is recalling 569 units of Centricity PACS-IW because a database error may cause image series to be missing from exams without user notification.
Arrow International is recalling 930 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life instead of 24 months.
Mayne Pharma is recalling 3,312 cans of Fabior (tazarotene) Foam, 0.1%, because stability testing showed high out-of-specification results for the active ingredient.
InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.
Southmedic, Inc. is recalling specific oxygen masks with EtCO2 sampling lines because loose or missing CO2 diffusers may render the masks non-functioning.
Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.
Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life.
The Binding Site Group is recalling 20 Optilite Beta-2-Microglobulin Urine Kits because they do not meet the stated antigen excess protection claim.
Koch Foods is recalling approximately 119,480 pounds of beef rib-shaped patties that may contain thin blue plastic pieces. No adverse reactions have been reported.
InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.
Phadia Ab is recalling Phadia Prime software versions up to 2.1.4 to prevent the use of the 'OK to All' function when rejecting and retesting EliA assay samples.
Siemens is recalling Syngo.via software because it fails to save corrected report values, potentially sending outdated information to physicians.
Halyard Health is recalling CORTRAK 2 feeding tubes because the internal stylet may be visible in the exit port window, deviating from specifications.
Pepsi Beverage Co is recalling 1,972 cases of Diet Pepsi because the cans are labeled to contain Sucralose but actually contain Aspartame.
Ventura Foods is recalling Gordon Choice Asian Sesame Ginger Dressing because blue plastic bag fragments were found in the product.
Josie's Homestyle Pralines are being recalled because the label incorrectly lists cream instead of evaporated milk and omits butter sub-ingredients.
Dynavox Systems LLC is recalling 4,615 T10 Speech Generating Devices because the internal battery may swell and cause the device case to separate.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement.
Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.
Phadia US Inc is recalling ImmunoCAP Allergen c5, Ampicilloyl test kits because stability specifications were not met.
Roche Diagnostics is recalling 47 units of the Elecsys BRAHMS PCT Immunoassay because it shows decreased recovery of patient samples on the cobas e 801 module compared to other analyzers.
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.
Zimmer Biomet is recalling 22 A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts due to incorrect color anodization.
Arrow International Inc. is recalling PleuraSeal Thoracentesis Kits because product packaging may not be completely sealed.
Arrow International Inc is recalling Pneumothorax Kits because the product packaging may not be completely sealed.
Arrow International is recalling Large Volume Abdominal Paracentesis Kits because the packaging may not be completely sealed.
Keystone is recalling 2018 Raptor and Carbon fifth-wheel trailers because missing fuel barriers allow absorption into the floor, increasing fire risk.
SynTec Seating Solutions is recalling S3B Restraint Wall Mounted Seats because the mounting bracket may crack, increasing injury risk in a crash.
BRP is recalling 2017 Can-Am Outlander and Outlander Max ATVs because the dynamic power steering shaft can break, causing a loss of steering control and crash hazard.
Indian Motorcycle is recalling 3,341 2018 models because corrosion in the combination switch may cause the bike to start unintentionally, posing a carbon monoxide risk.
Autocar is recalling 2018-2019 Xpeditor vehicles because a steering pinch bolt may not be properly tightened, potentially causing loss of steering control.
Motor Coach Industries is recalling 2018 MCI J4500 motor coaches because the rear left window may separate, creating a road hazard and increasing crash risk.
Motor Coach Industries is recalling 2018 J4500 vehicles because a wiring harness may contact the coolant tank, causing the left taillight to fail and reducing visibility.
J.T.M. Provisions is recalling approximately 14,525 pounds of pulled barbequed beef products that may contain rubber. The recall covers products shipped to Indiana, Kentucky, and Ohio.
Keystone is recalling specific Husky fifth wheel trailer hitches because fasteners may loosen, potentially causing the jaws to open unexpectedly and increasing crash risk.
Gulf Stream is recalling 2017-2018 Conquest motorhomes because federal placards may list an incorrect Gross Vehicle Weight Rating, potentially leading to vehicle overload.
Forest River is recalling 2018 Surveyor recreational trailers because the Federal Placard lists incorrect tire sizes and pressures, which could lead to over-inflation and increased crash risk.
Honda is recalling 2018 Pilot, Ridgeline, and Acura MDX vehicles because improperly manufactured seat rivets may break in a crash, increasing injury risk.
Mitsubishi is recalling 2004-2006 Lancers because passenger air bag inflators may explode during deployment, potentially causing serious injury or death.
Reading Truck Body is recalling specific panel bodies because a cracked rear cross member can damage turn signal wiring, increasing crash risk.
Brembo is recalling specific motorcycle front brake master cylinders because the internal piston may crack and fail, potentially causing a loss of front braking ability.
Newmar is recalling 2018-2019 New Aire motorhomes because a wheel valve stem stabilizer may dislodge, potentially causing tire damage and increasing crash risk.
Keystone RV is recalling 2018 Crossroads Cruiser and Volante trailers because improperly attached brake wires may cause braking loss or fire.
Doepker is recalling 2015-2016 53-foot Tridem Galvanized Highboy Flatdeck Semi trailers because lower rail main beam flanges may crack, potentially causing loads to shift and spill onto the road.
Spirit Halloween is recalling PAW Patrol Marshall hats with flashlights because the batteries can overheat, posing fire and burn risks. No injuries or fires have been reported.
Mizco International is recalling Re-fuel power bank charging stations sold at The Container Store because they can overheat, posing fire and burn hazards.
The FDA is recalling Red Zone Xtreme 3000 Capsules because FDA analysis found the product contains undeclared Tadalafil, an approved drug for erectile dysfunction.
Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.
Amneal Pharmaceuticals is recalling specific lots of Fosphenytoin Sodium Injection because of the presence of particulate matter.
Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.
Piggie Park Enterprises Inc. is recalling Maurice's Honey Southern Gold BBQ Sauce and Carolina Gold Honey Sauce because they contain undeclared soy and wheat ingredients.
Oregon Wild Berries, Inc. is recalling Chef Edwin's Mushroom Condensed Soup because the product was under-processed or the venting schedule was not followed.
Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.
Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
Taylor Farms is recalling diced yellow onions after routine testing confirmed a positive result for Salmonella. The product was distributed to food service locations in 11 states.
Apollo Care is recalling 144 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.
Lancaster Fine Foods Inc. is recalling 1.5 oz. cups of Thai Sweet Chili Sauce because some cups were mislabeled as Spicy Mayonnaise Sauce.
Wegmans is recalling Avocado Summer Rolls packaged with Thai Sweet Chili Sauce because the sauce contains undeclared egg.
RaySearch Laboratories is recalling Ray Station 4.9 through 7 software due to a defect that may result in incorrect treatment volumes being delivered to patients.
Vornado Air is recalling about 350,000 VH101 Personal Vortex electric space heaters because they can overheat, posing fire and burn hazards.
Wegmans is recalling Thai Sweet Chili Sauce cups because they contain undeclared egg, a major food allergen.
Ford is recalling 2018 F-650, F-750, F-150, and Expedition vehicles because a gear shift cable clip may not be seated, causing the transmission to be in a different gear than indicated.
Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
Wegmans is recalling Assorted Gyoza packaged with Thai Sweet Chili Sauce because the sauce contains undeclared egg.
Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.
Zero Motorcycles is recalling 2012 S, DS, and DSP models because battery wear may cause electrical shorts and fire. Owners should stop riding and charging these vehicles.
Ford is recalling 2017-2018 F-150, Expedition, Mustang, and Navigator vehicles because a missing transmission roll pin may cause the vehicle to roll away from Park.
Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.
Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed clinical analysis for survivorship.
Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.
Konica Minolta is recalling 88 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage that may cause smoke emission.
Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length implants.
Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.
Schwartz Brothers Bakery is recalling 106 units of Gourmet Cream Cheese Cinnamon Rolls due to undeclared egg. The product was distributed in Washington.
Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.
Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because they may drift during use, potentially causing unintended movement.
Becton Dickinson is recalling 1,976,000 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes because increased residual blood was found on the top of the stopper well after venipuncture.
Cook Inc. is recalling 21 Marrs Laparoscopic GIFT Catheters because they were distributed without completed quality testing, posing a risk of nonviable embryos.
Medica Corporation is recalling EasyCAL HbA1c Calibrator kits because patient results may deviate up to 20 percent.
Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.
Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
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