Archive
863 recalls were announced in August 2018.
Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.
Which agencies issued them
Pharmalucence, Inc. is recalling 95 kits of Technetium TC 99M Medronate due to a reported breach of sterility. The affected product is distributed nationwide.
YWAM Faith Harvest Helpers is recalling 4,818 cans of salmon because the firm lacked a scheduled process for manufacturing low-acid canned food.
Guardian Pharmacy Services is recalling 2,400 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.
NuCare Pharmaceuticals is recalling Valsartan/HCTZ 320/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
Guardian Pharmacy Services is recalling 442 syringes of Hyaluronidase 150 units/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 5,000 bags of Ascorbic Acid 500 mg/mL TPN in Texas due to lack of sterility assurance.
Guardian Pharmacy Services is recalling 100 syringes of compounded Glycopyrrolate 0.2 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling Cefazolin 2 Gm/20 mL syringes in Texas due to a lack of sterility assurance.
Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.
Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.
Guardian Pharmacy Services is recalling specific lots of compounded Morphine Sulfate 1 mg/mL CADD 25 mL due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL ON-Q Pumps due to a lack of sterility assurance. The products were distributed in Texas.
Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.
Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.
Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.
Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL pre-filled syringes due to a lack of sterility assurance. The product was distributed in Texas.
Guardian Pharmacy Services is recalling 40 vials of Phenol 6% with Glycerin Injection in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling 60 vials of compounded Medroxyprogesterone 150 mg/mL in Texas due to a lack of sterility assurance.
NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 160/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Longbow First Aid Products Manufactory is recalling 30,000 bottles of Emergency First Aid Eyewash due to CGMP deviations. The product was distributed in New York and California.
Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Guardian Pharmacy Services is recalling 100 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.
World Organix, LLC is recalling Blissful Remedies 4 Hour Chill herbal shots due to potential high microbial loads. The affected products were distributed nationwide.
Winnebago is recalling 2012-2013 Era, View, Via, Itasca Navion, and Reyo motorhomes because high-pressure propane hoses may harden and leak, increasing fire risk.
Polaris is recalling 2017-2019 Slingshot motorcycles because the seatbelt retractor may separate in a crash, preventing the belt from locking and increasing injury risk.
Guardian Pharmacy Services is recalling 1,000 vials of Magnesium Sulfate 200 mg/mL in Texas due to a lack of sterility assurance.
Guardian Pharmacy Services is recalling Hyaluronidase 150 units/mL vials in Texas due to a lack of sterility assurance.
Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
World Organix, LLC is recalling Blissful Remedies Red Maeng Da capsules due to potential high microbial loads. The recall covers 789 pouches distributed nationwide.
Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.
Guardian Pharmacy Services is recalling 95 vials of Methylene Blue 10 mg/mL in 1 mL syringes due to a lack of sterility assurance. The product was distributed in Texas.
Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream because routine stability testing found an unknown impurity.
Xtava is recalling approximately 235,000 Allure and Allure Pro hair dryers because the units and power cords can overheat, catch fire, or cause electrical shock.
Guardian Pharmacy Services is recalling 250 vials of MIC B Combo Lipotropic in Texas due to a lack of sterility assurance.
Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.
Water Pik, Inc. is recalling 3,797 Waterpik Sonic-Fusion Professional units because the charging base may overheat, melt, or spark, posing fire, shock, or burn risks.
Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL in ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.
World Organix, LLC is recalling Blissful Remedies Red Maeng Da Liquid Kratom due to potential high microbial loads. The product was distributed nationwide in the USA.
Kraft Heinz is recalling Taco Bell Salsa Con Queso Mild jars nationwide due to a risk of Clostridium botulinum growth.
World Organix LLC is recalling Blissful Remedies Kratom+CBD capsules due to potential high microbial loads. The affected products were distributed nationwide.
Whole Foods Market is recalling Lemon Raspberry Cake made in Mid-Atlantic stores because it failed to declare soy flour as an ingredient.
NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.
Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.
Howmedica Osteonics Corp. is recalling 180 sterile-packed radial stem implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 546 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.
Pepperidge Farm is recalling specific Goldfish cracker cases due to potential Salmonella in whey powder used in seasoning.
Howmedica Osteonics Corp. is recalling 45 rHead Standard Extended Stem implants because literature suggests a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 201 units of the rHead Radial Implant 6 mm Collar, Size 1, because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 158 Radio Capitellum Large, Right orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Vitale Brothers Bakery is recalling 134 loaves of Italian bread sold in Michigan due to undeclared wheat, a major allergen.
Howmedica Osteonics Corp. is recalling 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 310 units of the rHead Recon Stem Implant, Size 4, because the revision rate is higher than other similar devices.
Think Surgical is recalling 951 flat cutters used in total knee arthroplasty because the cutter head may detach from the shaft.
Forest River is recalling 2019 Prime Time Tracer and Avenger travel trailers because a missing oven diverter can cause the countertop to become extremely hot, increasing the risk of burn injuries.
Whole Foods Market is recalling various bakery products from Mid-Atlantic stores sold between May 25 and July 13 due to undeclared soy flour.
Natus Neurology is recalling 797 ErgoJust mobile video carts because a manufacturing defect may cause the video pole to fail.
Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem Size 3 orthopedic implants due to a higher-than-expected revision rate.
Howmedica Osteonics Corp. is recalling 36 units of rHead Standard Extended Stem implants due to a higher-than-expected revision rate and potential performance issues.
Howmedica Osteonics Corp. is recalling 285 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate than similar devices.
Howmedica Osteonics Corp. is recalling 301 rHead Stem Implant Plasma Coated, Size 4 units because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 162 units of rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 285 rHead Stem Implant Plasma Coated, Size 2 units because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 150 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 605 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Aldi is voluntarily recalling AnnaSea Limu Ahi Poke Hawaiian Poke Kits because they were stored at temperatures above freezing, which can make them unsafe to eat.
Smiths Medical ASD Inc. is recalling 276 Medfusion Syringe Infusion Pumps because a ridge in the Barrel Clamp Guide may cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
Pepperidge Farm is recalling specific Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.
Howmedica Osteonics Corp. is recalling 270 rHead Stem Implant Plasma Coated, Size 1 units because literature indicates a higher revision rate than other similar devices.
Arjohuntleigh Magog is recalling Q-Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.
Howmedica Osteonics Corp. is recalling 141 rHead Recon Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 81 units of Stryker rHead Radial Head Implant Assemblies because literature indicates higher revision rates than similar devices.
Howmedica Osteonics Corp. is recalling 107 Radial Head Assy Size #4 implants because literature review indicates higher revision rates than other devices.
Howmedica Osteonics Corp. is recalling 286 units of the rHead Radial Implant 6 mm Collar, Size 4, because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 66 units of rHead Standard Extended Stem implants due to higher-than-expected revision rates.
Constantine's International Foods is recalling JouJou's white large pita bread because the packaging failed to declare wheat as an ingredient.
Pepperidge Farm is recalling specific Goldfish Baked Snack Crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.
Vitale Brothers Bakery is recalling 31 loaves of Onion Rolls sold in Michigan due to undeclared wheat.
Howmedica Osteonics Corp. is recalling 170 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Marketing Concepts Group is recalling FUSIA Spicy Mongolian Noodle Bowls because the inner packaging contains undeclared peanuts.
Howmedica Osteonics Corp. is recalling 544 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 265 rHead Recon Stem Implant 6mm Collar, Size 1 units because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 211 Stryker rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 396 rHead Recon Stem Implant Plasma Coated, Size 3 units because literature reviews indicate a higher revision rate than other similar devices.
Flowers Foods is recalling Swiss Rolls snack cakes sold under multiple brands due to potential salmonella contamination in a whey powder ingredient.
Howmedica Osteonics Corp. is recalling 121 Radio Capitellum Small, Right orthopedic implants because literature reviews indicate a higher revision rate than expected.
Howmedica Osteonics Corp. is recalling 214 Radio Capitellum Small, Left orthopedic implants because literature reviews indicate higher revision rates than similar devices.
Howmedica Osteonics Corp. is recalling 607 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 90 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Volvo is recalling 2019 XC40 vehicles because rear seat back lock strikers may be missing. This defect could allow the seat back to move forward during hard braking or a crash, increasing injury risk.
BMW is recalling three 2019 430i and 440i vehicles because the front passenger air bag inflator may be defective, potentially affecting deployment in a crash.
Whole Foods Market is recalling specific vanilla Panibois dessert shells sold in the Mid-Atlantic region because they failed to declare soy flour as an ingredient.
Hickory Springs is recalling NextGen School Bus seats with Integrated Child Restraint Systems because they may be missing a warning label on the lower restraint strap.
Whole Foods Market is recalling bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.
Whole Foods Market is recalling Italian Rum cakes from Mid-Atlantic stores sold between May 25 and July 13, 2018, due to undeclared soy flour.
Whole Foods Market is recalling 1,872 units of 1.0-pound Banana Parfaits made in Mid-Atlantic stores because they failed to declare soy flour as an ingredient.
Whole Foods Market is recalling bakery products from Mid-Atlantic stores sold between May 25 and July 13 because they failed to declare soy flour as an ingredient.
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