Archive
516 recalls were announced in April 2019.
Of the 516 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.
Which agencies issued them
Anderson Compounding Pharmacy is recalling HCG 40 Day Injection Extra Strength vials nationwide due to a lack of sterility assurance.
Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 60:30:1 Injection due to a lack of sterility assurance. The recall covers all lots distributed nationwide.
Gyrus ACMI is recalling 193 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.
Abbott is recalling 559 Alinity c Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.
BioFire Diagnostics is recalling FilmArray BCID Panels used with specific BACT/ALERT blood culture bottles due to an increased risk of false positive results for Enterobacteriaceae and E. coli.
bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.
Teva Pharmaceuticals is recalling specific lots of Amoxicillin Oral Suspension because assay results were below specification limits. The affected bottles were distributed nationwide and in Puerto Rico.
Gyrus ACMI is recalling 82 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
Anderson Compounding Pharmacy is recalling Prostaglandin 40 mcg/mL vials nationwide due to a lack of sterility assurance.
Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.
Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.
InvaGen Pharmaceuticals is recalling Testosterone Cypionate Injection vials due to the presence of particulate matter. The affected lots were distributed nationwide in the U.S.A.
Gyrus ACMI is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
Gyrus ACMI is recalling 161 Diego Elite Malleable 4mm Standard Monopolar Blades because they may allow unintended RF energy activation when used with Diego Elite consoles.
ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.
Bioventus is recalling 10,793 units of Bioactive Bone Graft Putty because sterile pouches may puncture during transit, potentially introducing non-sterile devices and causing patient infection.
Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.
ICU Medical is recalling specific lots of ChemoClave Vented Vial Spikes because they may contain plastic burr particulate from the protective cap.
Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.
Anderson Compounding Pharmacy is recalling Methylprednisolone 1% PF Ophthalmic drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.
GE Healthcare is recalling 49 Innova IGS 630 Interventional Fluoroscopic X-Ray Systems due to a potential loss of x-ray imaging function when changing the field of view while releasing the footswitch.
Medrobotics is recalling 35 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.
ProSun International is recalling nine specific tanning beds due to quality control documentation discrepancies that could result in high UV output.
ProSun International is recalling 31 Onyx 32 Sli Intensive tanning beds due to quality control documentation discrepancies that could result in high UV output.
GE Healthcare is recalling one Innova IGS 630 angiographic X-ray system because a specific user action may cause a loss of imaging function.
Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.
Boston Salads & Provisions Co., Inc. is recalling 915 pounds of Edamame Salad due to possible metal fragment contamination. The product was distributed in MA, CT, RI, NH, and NY.
GE Healthcare is recalling 22 Innova IGS 6 Interventional Fluoroscopic X-Ray Systems because they may lose x-ray imaging function during specific field of view changes.
Medrobotics is recalling 24 Flex Robotic System obturators because a weld may break, causing the rod to separate from the cone.
Anderson Compounding Pharmacy is recalling 35 vials of Estradiol Cypionate 10 mg/mL due to a lack of sterility assurance. The product was distributed nationwide.
Gyrus ACMI is recalling 13 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with compatible consoles.
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Siemens Healthcare Diagnostics is recalling 449 syngo Lab Data Manager systems due to software issues. The recall covers systems distributed in the US and nine other countries.
ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.
Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product inside may not match the sales unit carton and foil label.
Philips is recalling 23 Brilliance 16 Air CT systems because a collimator component may fail, causing image artifacts.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper systems because pedals may bend, causing an inability to make live fluoroscopy images or exposures.
ConAgra Foods is recalling 145,380 cans of Hunts Tomato Paste No Salt Added due to potential mold caused by can damage.
PepsiCo is recalling specific 12 fl. oz. Diet Pepsi cans because the outer case lists Aspartame while the individual can wrap states the product is Aspartame free.
Wholesome Treats, Inc. is recalling Breads from Anna Yeast Free Bread Mix because the product contains undeclared flaxseed, which is not listed on the label.
Wholesome Treats, Inc. is recalling Breads from Anna Classic Herb Bread Mix because the product contains undeclared flaxseed.
Dr. Reddy's Laboratories is recalling Divalproex Sodium Extended-Release Tablets because they were exposed to high humidity during packaging.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Ethicon, Inc. is recalling VICRYL, VICRYL Plus, and PDS sutures because the product may not match the sales unit carton and foil label.
Philips Medical Systems is recalling 7,209 foot switches used with specific imaging systems because bent pedals may prevent live fluoroscopy images or exposures.
Topcon Medical Systems is recalling IMAGEnet 6 software due to a defect that may display incorrect patient identification information alongside thumbnails.
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle prostheses because the labels incorrectly identify the metallic coating material.
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle implants because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Philips is recalling 14 Brilliance 64 CT systems because a component may fail, causing ring or smudge artifacts on images.
Integra LifeSciences Corp. is recalling Tibial Total Ankle Prosthesis Trays because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.
Integra LifeSciences Corp. is recalling Tibial Total Ankle Prosthesis Trays because the labels list an incorrect metallic coating material symbol.
Wholesome Treats, Inc. is recalling Breads from Anna Black Bean Brownie Mix due to undeclared flaxseed.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling 2,029 Tibial Total Ankle Prosthesis Trays because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences Corp. is recalling Talar Dome Total Ankle Prostheses because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling 2,029 Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Tibial Total Ankle Prosthesis Trays due to incorrect metallic coating symbols on labels and instructions.
Wholesome Treats, Inc. is recalling Breads from Anna Dairy & Corn Free Bread Mix because the product contains undeclared flaxseed.
Cays LLC is recalling 2,095 bottles of Addback Tablets because the product contains undeclared coating ingredients and lists an ingredient not in the formulation.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved when it is non-valved.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Wholesome Treats, Inc. is recalling Breads from Anna Banana Bread Mix because the product contains undeclared flaxseed.
InvaGen Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because of the presence of particulate matter. The affected vials were distributed nationwide.
InvaGen Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because they contain particulate matter.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays due to incorrect metallic coating material symbols on labels and instructions.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels incorrectly identify the metallic coating material.
Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly list the metallic coating material symbol.
Aniara Diagnostica LLC is recalling 41 units of BIOPHEN UFH Control C1 because incorrect versions of the Instructions for Use were packaged into specific lots.
ICU Medical is recalling specific lots of ChemoLock Vial Spikes because they may contain plastic burr particulate from the protective cap.
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.
ICU Medical is recalling specific lots of ChemoLock devices because they may contain plastic burr particulate from the protective cap.
Cordis Corporation is recalling Vista Brite Tip and Androit guiding catheters because frayed pieces of the mounting card were found inside the primary packaging.
Johnson Matthey Inc. is recalling Remifentanil HCl active pharmaceutical ingredient (API) because an unknown impurity exceeded specification limits.
Estee Lauder Inc is recalling 14,490 jars of Repairwear Laser Focus Line Smoothing Cream SPF 15 because the seal between the cap and jar is ineffective.
Aniara Diagnostica LLC is recalling 14 kits of BIOPHEN UFH Control C2 because incorrect Instructions for Use were packaged with the product.
Toyota is recalling 2019 Sienna vehicles because incorrect welds in the passenger front door may affect air bag sensor readings, potentially causing unintended deployment or failure to deploy.
Toyota is recalling 2015-2017 Yaris vehicles because wire harnesses for side air bag sensors may crack and corrode, potentially causing air bags to fail to deploy or deploy improperly.
K2D Foods is recalling approximately 113,424 pounds of raw ground beef products due to possible E. coli O103 contamination. The products were distributed to restaurants in Florida and Georgia.
Bodum is recalling CHAMBORD stove top espresso makers because the handle can ignite from gas stove flames, posing fire and burn risks.
Flying Tiger Copenhagen is recalling wooden toy train carts because a steam dome can detach, creating a choking hazard for children.
American Fastbacks is recalling 2018 Jeep Wranglers with roof top tents because the cover may crack and detach while driving, creating a road hazard.
Toyo is recalling specific Proxes A27 tires where a rubber compound error may cause tread to detach, increasing crash risk.
Forest River is recalling 2019 Rockwood and Flagstaff recreational trailers because improperly installed air conditioning wiring may contact a heat strip, increasing the risk of fire.
Bendix is recalling ADB22X Air Disc Brake Calipers for school buses because the driver side rear brakes may drag, increasing the risk of fire.
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