Archive
850 recalls were announced in April 2017.
Of the 850 recalls this month scored against our rubric, 12% are Critical, 18% are Severe.
Which agencies issued them
Siemens Medical Solutions is recalling three Combi Dockable Neurosurgery tables for MRI systems due to a potential manufacturing error that could cause a sudden drop in table height.
Dolcetta Artisan Sweets is recalling 250 Rosemary Caramel Bars in Oregon and Washington due to undeclared soy lecithin.
J & J Distributing Company is recalling Kowalski's Markets Carrot, Apple, Hummus Wraps and Vegetable Wraps because shredded carrots used in the products were contaminated with metal pieces.
Dolcetta Artisan Sweets is recalling 400 Milk Chocolate Pretzel Bars distributed in Oregon and Washington due to undeclared soy lecithin and wheat.
Dolcetta Artisan Sweets is recalling 90 bags of Dark Chocolate Peppermint Snowflakes in Oregon and Washington due to undeclared soy lecithin.
Dolcetta Artisan Sweets is recalling 80 Dark Chocolate Hazelnut Bars distributed in Oregon and Washington due to undeclared soy lecithin.
BioMerieux SA is recalling VIDAS Estradiol II kits because Fulvestrant treatment can cause falsely elevated estradiol results.
Dolcetta Artisan Sweets is recalling 300 Dark Chocolate Coconut Bars distributed in Oregon and Washington due to undeclared soy lecithin and milk.
Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.
ConMed is recalling Hyfrecator 2000 accessory packages because they contained non-sterile handpiece sheaths labeled as sterile.
GE Healthcare is recalling Vivid E95, E90, and E80 ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.
Dolcetta Artisan Sweets is recalling 30 boxes of Dark Chocolate Pretzel Santa because the product contains undeclared soy lecithin.
Dolcetta Artisan Sweets is recalling 20 boxes of Dark Chocolate Toffee Santa because the product contains undeclared soy lecithin.
Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.
Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.
Windstone Medical Packaging is recalling 12 Ortho Basic Packs because the sterile packaging of the included eye pads may be compromised.
The SoyNut Butter Company is recalling I.M. Healthy Unsweetened SoyNut Butter due to potential E. coli O157 contamination. Consumers should stop using the product.
Companion Foods Corp. is recalling Vegetarian Minced Meat with Shiitake because an FDA inspection found wheat was not properly declared in the ingredient list.
Windstone Medical Packaging is recalling 1,330 Eye Packs because the sterile packaging of the included eye pads may be compromised.
Dolcetta Artisan Sweets is recalling 180 boxes of Hazelnut Truffles distributed in Oregon and Washington because the product contains undeclared soy lecithin.
Aesculap Implant Systems LLC is recalling the Minop InVent 30 Trocar System because sharp edges may abrade insulation during use.
Micromedics, Inc. is recalling 273 units of FibriJet Endoscopic Catheter Introducers because small channels in the sterile packaging seal may compromise package integrity and sterility assurance.
J & J Distributing Company is recalling Kowalski's Markets Protein Powerhouse because shred carrots used as an ingredient were contaminated with metal pieces.
Windstone Medical Packaging is recalling Vitrectomy Kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Dolcetta Artisan Sweets is recalling Salted Caramel Bonbons because the product contains undeclared soy lecithin, a major food allergen.
Bak EZ is recalling 7-Eleven Mantecada Muffins because they contain milk, which is not listed on the label.
Dolcetta Artisan Sweets is recalling Peppermint Caramel Truffles because the product contains undeclared soy lecithin and milk. The recall affects 100 boxes distributed in Oregon and Washington.
Dolcetta Artisan Sweets is recalling 98 boxes of Espresso Caramels sold in Oregon and Washington due to undeclared soy lecithin.
The SoyNut Butter Company is recalling I.M. Healthy Honey Creamy SoyNut Butter due to potential E. coli O157 contamination.
Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a software issue can cause rack crashes and sample spillage, posing a risk of exposure to infectious material.
Dolcetta Artisan Sweets is recalling Assorted Bonbons because they contain undeclared soy lecithin. The product was distributed in Oregon and Washington.
Companion Foods Corp. is recalling Braised Bamboo Shoot Tips because wheat is not properly declared in the ingredient list.
ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.
Dolcetta Artisan Sweets is recalling Maple-Pepper Caramels because they contain undeclared soy lecithin and milk. The product was distributed in Oregon and Washington.
Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
RaySearch Laboratories is recalling RayStation software due to a potential calculation error in non-standard Citrix environments.
Windstone Medical Packaging is recalling 100 Vitrectomy Packs because the sterile packaging of the included eye pads may be compromised.
Companion Foods Corp. is recalling Szechuan Style Kung-Pao Sauce because wheat is not properly declared in the ingredient list, posing a risk to individuals with wheat allergies.
The SoyNut Butter Company is recalling I.M. Healthy Apple Granola due to potential E. coli O157 contamination. The product was distributed nationwide.
J&J Distributing Company is recalling Kowalski's Markets Salad Super Kale because shred carrots used as an ingredient were contaminated with metal pieces.
Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.
ConMed is recalling Hyfrecator 2000 handpiece sheaths because non-sterile units were packaged in pouches labeled as sterile, posing a risk of infection.
Dolcetta Artisan Sweets is recalling Dark Chocolate Pretzel Bars because they contain undeclared soy lecithin and wheat.
Companion Foods Corp. is recalling Braised Bamboo Shoot Tips with Chili because an FDA inspection found wheat was not properly declared in the ingredient list.
The SoyNut Butter Company is recalling I.M. Healthy Raisin & Cranberry Granola due to potential E. coli O157 contamination.
Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.
Windstone Medical Packaging is recalling 376 plastic kits containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.
Dolcetta Artisan Sweets is recalling Hot Cocoa Snowballs because they contain undeclared soy lecithin, a common allergen.
Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.
Dolcetta Artisan Sweets is recalling 360 boxes of Salty Caramel Truffles in Oregon and Washington due to undeclared soy lecithin and milk.
Companion Foods Corp. is recalling Braised Bean Curd (Mock Chicken) because wheat is not properly declared as a sub-ingredient in the ingredient list.
Dolcetta Artisan Sweets is recalling 30 bags of Milk Chocolate Almond Toffee Tree in Oregon and Washington due to undeclared soy lecithin.
Volcano Corporation is recalling 718 Refinity Rotational Intravascular Ultrasound Catheters because high complaint rates indicate kinking near the proximal shaft, which could disrupt clinical workflow or cause loss of imaging.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Neck Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.
2k Innovations is recalling 22,757 Volt Resistance Heated Elbow Garments because FDA inspections found the firm made unapproved therapy and medical claims.
Windstone Medical Packaging is recalling 16 ENT kits because the sterile packaging of the included Medtronic eye pads may be compromised.
Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP Reagent Packs because background signals are increasing, causing calibration failures.
Windstone Medical Packaging is recalling 260 Lasik Tray kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.
Medisca, Inc. is recalling Estriol, USP (Micronized) Bulk in various bottle sizes due to cGMP deviations identified during an FDA inspection.
Medisca, Inc. is recalling Estradiol, USP (Hemihydrate) (Micronized) API products due to cGMP deviations identified during a recent FDA inspection.
Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because they failed impurity specifications.
Medisca, Inc. is recalling Estradiol, USP Bulk (Hemihydrate) in 25 g and 100 g bottles due to cGMP deviations identified during an FDA inspection.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Foot Wraps because FDA inspections found unapproved therapy and medical claims on product information and the company website.
Qinhuangdao Zizhu Pharmaceutical is recalling Estradiol Micronized Bulk for prescription compounding due to cGMP deviations and lack of quality assurance.
The FDA is recalling bulk levonorgestrel manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.
2k Innovations Inc. is recalling Volt Resistance Frostie Heated Gloves because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.
Myers Cider Mill LLC is voluntarily recalling 100% Apple Cider due to a process deviation. The product was sold in Ohio.
Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.
2k Innovations Inc. is recalling Volt Resistance Heated Slippers because FDA inspections found the product makes unapproved therapy and medical claims.
Merit Medical Systems is recalling 1,940 PreludeSYNC Radial Compression Devices because manufacturing particulates may prevent the inflation valve from sealing completely.
Signature Club A Ltd is recalling 1,237 jars of Double Hyaluronic 1000 Volumizing Day Cream due to microbial contamination.
Citron Pharma LLC is recalling 420 bottles of Penicillin V Potassium 500 mg tablets because Amoxicillin 500 mg tablets were found in the bottles.
Qinhuangdao Zizhu Pharmaceutical is recalling bulk Estriol Micronized, USP, due to cGMP deviations and lack of quality assurance. The product is distributed to pharmacies in six states for prescription compounding.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Lower Back Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.
Keystone Dental Inc. is recalling 59 PrimaConnex Straight Implants because they were incorrectly labeled as Tapered Implants.
2k Innovations is recalling Volt Resistance Heated Socks because FDA inspections found the product makes unapproved therapy and medical claims.
Windstone Medical Packaging is recalling 20 PRK kits because the sterile packaging of the included eye pads may be compromised.
2k Innovations Inc. is recalling Volt Resistance Heated Slippers because the firm made unapproved therapy and medical claims on product information and its website.
Companion Foods Corp. is recalling Fat-Choy Style Vegetable Soup because an FDA inspection found wheat was not properly declared in the ingredient list, despite being listed in the Contains statement.
Companion Foods Corp. is recalling Vegetarian Tuna Fish cans because an FDA inspection found wheat was not properly declared in the ingredient list.
GE Healthcare is recalling 118 units of Centricity PACS Web Diagnostic software due to a defect where study category labels and hanging positions appear incorrectly swapped.
Classik Foods Inc. is voluntarily recalling Maggi 2 Minute Noodles in Florida and Georgia due to misbranding. No illnesses have been reported.
Lian Hwa Foods is recalling Good Plenty Supreme Abalone Noodles because wheat was not properly declared on the label.
2k Innovations Inc. is recalling Volt Resistance Heated Therapy Knee Wraps because FDA inspections found the product makes unapproved therapy and medical claims.
Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.
Boston Scientific is recalling Imager II Angiographic Catheters because some packages are mislabeled as Contra 2 curve catheters when they contain Contra curve catheters.
The FDA is recalling bulk Estradiol Non-Micronized, USP, manufactured by Qinhuangdao Zizhu Pharmaceutical, Co. due to cGMP deviations and lack of quality assurance.
McKesson Medical Surgical is recalling 98 vials of Hydralazine Hydrochloride Injection because some were stored refrigerated instead of at room temperature.
Cardiovascular Systems Inc. is recalling one lot of ViperWire Advance Peripheral Guide Wires because they may contain the wrong size product.
2k Innovations is recalling Volt Resistance Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Shoulder Wraps because the firm made unapproved therapy and medical claims on product information and its website.
2k Innovations Inc. is recalling Volt Resistance Unisex Rechargeable Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets due to high levels of a degradation product.
West-Ward Columbus, Inc. is recalling Doxercalciferol Capsules 0.5mcg because capsules were found with illegible print during an internal inspection.
Smiths Medical is recalling CADD Administration Sets because the illustration on the Instructions for Use incorrectly depicts the filter size as 2.0 microns instead of the actual 0.2 microns.
Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because high levels of a degradation product were detected.
Allergan is recalling 56,878 bottles of Lumigan (bimatoprost) 0.01% ophthalmic solution because the product failed impurities and degradation specifications.
Novel Laboratories is recalling 7,656 bottles of Fluocinolone Acetonide Topical Solution 0.01% due to chemical contamination. The affected product was distributed nationwide.
Navistar is recalling 336 school buses because an unfused electrical circuit in the heater booster pump may increase the risk of a fire.
Cummins is recalling ISV5.0 diesel engines in Tiffin Breeze motorhomes because a fan support bearing may fail, causing the engine to stall and increasing crash risk.
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