Archive
833 recalls were announced in February 2018.
Of the 833 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.
Which agencies issued them
Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products.
Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.
Synthes USA is recalling 5 units of Norian Drillable Inject because kit expiration dates do not align with the earliest component expiration dates.
Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.
Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.
Gibson Laboratories LLC is recalling Blastomyces dermatitidis Antiserum vials because the product was reporting false positive results.
Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.
General Mills is recalling Larabar Chocolate Chip Cookie Dough bars because they may contain individually wrapped Coconut Cream Pie Bars.
Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.
Sage Products Inc is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
B. Braun Medical is recalling PENCAN Spinal Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
Sage Products Inc. is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products Inc. is recalling QCare Rx Oral Cleansing and Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.
Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.
Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
B. Braun Medical is recalling 11,920 units of Pencan Spinal Needle Trays because they contain loose polypropylene foreign matter above release specifications.
Sage Products Inc. is recalling Toothette Oral Care Suction Swabs because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
B. Braun Medical is recalling Perifix Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.
Cook Inc. is recalling 304 Spectrum Central Venous Catheter Trays because the catheters may not fit over the guide wire, potentially causing procedure delays.
Hetero Labs Limited is recalling 8,436 bottles of Famciclovir 500 mg tablets because high temperatures during distribution caused the tablets to become wet, stuck together, and disintegrated.
Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling the Nose to Toes Skin Antisepsis System because oral care components were manufactured on equipment shared with non-pharmaceutical products.
Arrow International Inc is recalling Radial Artery Catheterization Sets due to the presence of loose polypropylene foreign matter above release specifications.
Cook Inc. is recalling specific lots of Central Venous Tray Triple Lumen Polyurethane Catheters because they may not fit over a guide wire, potentially causing procedure delays.
Sage Products is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution due to potential cross-contamination with non-pharmaceutical products.
B. Braun Medical is recalling 460 Pain Management Trays containing 22GA SafetyGlide Needles due to the presence of loose polypropylene foreign matter.
Kingston Pharma LLC is recalling 13,536 bottles of Live Better Drug Free Black Elderberry Syrup because gas is developing in the sealed bottles.
Sage Products Inc is recalling Q.CARE Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products is recalling 9,006 cases of QCare RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products Inc. is recalling Toothette Oral Care Q Care & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products is recalling Toothette Oral Care Perox-A-Mint Solution packets due to cross-contamination with non-pharmaceutical products during manufacturing.
Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.
Sage Products Inc. is recalling QCare Oral Cleansing and Suctioning Systems with Corinz due to cross-contamination with non-pharmaceutical products during manufacturing.
B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter.
Zimmer Surgical is recalling 8,231 A.T.S. 2200TS Tourniquet Systems to update on-device labels and operator manuals regarding RF communication equipment separation distances.
Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.
Ross Acquisitions Company is recalling Star Wars tin caramel popcorn due to a customer report of grain beetles in the product.
Improper Goods is recalling Hibiscus Lavender Syrup because production records showed the internal fill temperature was below 165°F.
BYL Solutions Inc. is recalling Bull Capsules marketed without an approved NDA/ANDA and found to be tainted with sildenafil.
Sage Products Inc. is recalling 879 cases of Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Sage Products is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Aesculap Implant Systems LLC is recalling 292 units of the JS Series SterilContainer S2 System because they were released to the market before receiving authorized FDA 510K clearance.
Sage Products Inc. is recalling 150 cases of skin antisepsis and oral cleansing kits due to cross-contamination risks from shared manufacturing equipment.
DePuy Orthopaedics is recalling 21 units of CORAIL COXA VARA High Offset Stem because the packages contained the wrong device model.
Sage Products Inc. is recalling the Toothette Oral Care Short Term Oral Care System because it was manufactured on equipment shared with non-pharmaceutical products.
Sage Products is recalling Q Care RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Sage Products is recalling Q CARE q4 Oral Cleaning & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or type, potentially delaying patient treatment.
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes due to cross-contamination with non-pharmaceutical products during manufacturing.
Medtronic is voluntarily recalling specific Clip Gun Scalp Clip Kits and Applicators because they did not meet current packaging performance standards.
Webrx dba RxPalace.com is recalling BonaDur For Men lidocaine spray because it was not manufactured according to current good manufacturing practices.
Improper Goods is recalling Lemon Ginger Syrup because the internal fill temperature was not recorded. The product was distributed in nine states.
AMEDA is recalling specific lots of Purely Yours Breast Pumps because they were manufactured with a UK power adapter instead of the correct one.
Allergan is recalling 8 bottles of NORCO tablets because the primary label is missing the required CII controlled drug classification indication.
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% because it failed a droplet size stability test. The recall covers 17,554 bottles distributed nationwide.
Genentech is recalling Klonopin (clonazepam) 0.5 mg tablets because the Schedule IV controlled substance indicator was omitted from the product carton.
Kaufman is recalling 189 2018 Double Deck Car Haulers because incorrect axle spindles may fail, causing wheel detachment and increasing crash risk.
Toyota is recalling 2018 Tundra and Sequoia vehicles because electrical interference may deactivate the electronic stability control system, increasing crash risk.
Night Hawk Frozen Foods is recalling approximately 167 pounds of frozen beef patty and gravy products because they contain undeclared milk, a known allergen.
Kaufman is recalling 2018 Double Deck Car Hauler trailers because incorrect axle spindles may fail, causing wheel detachment and increasing crash risk.
Toyota is recalling 2017 Tundra vehicles because a rear seat leg bracket may not be properly tightened, increasing injury risk in a crash.
Navistar is recalling 2016-2019 IC Bus CE school buses with 8.8L LPG engines because a relay may fail, causing the fuel pump to stop and the bus to stall.
NEMO Equipment is recalling Stargaze Recliner chairs because seat straps can fail, posing a fall hazard. No injuries have been reported.
Navistar is recalling 2018 IC Bus CE transit buses with 8.8L LPG engines because a relay may fail, causing the fuel pump to stop and the bus to stall.
Whirlpool is recalling KitchenAid electric kettles because the handle can separate, causing hot liquid to spill and posing a burn risk.
Hino is recalling 2018-2019 NE8J, NH8J, NJ8J, and NV8J trucks because loose fuse terminal bolts may cause electrical arcing, overheating, or engine shutdown.
Keystone RV is recalling 2018 Crossroads Zinger and Longhorn trailers because an improperly installed ground wire may cause an electrical short and fire.
Karma Automotive is recalling 2018 Revero vehicles because side curtain air bags may partially detach during deployment, increasing injury risk in a crash.
Thor Motor Coach is recalling 2018-2019 Outlaw model 29J recreational vehicles because the sofa seat belt bracket may not meet strength requirements, increasing injury risk in a crash.
Hyundai is recalling 2018 Santa Fe and Santa Fe Sport vehicles because the steering wheel assembly may break and separate from the column while driving.
Nova Bus is recalling 2013 LFS transit buses because a transmission oil cooler failure could cause hot coolant to leak into the passenger area, posing a risk of injury.
Keystone is recalling 2018 Summerland 1800BH trailers because an improperly sealed refrigerator may allow carbon monoxide or propane to enter the living area.
Daimler Trucks North America is recalling 2018 Freightliner MT45G and MT55G vehicles because a capacitor bracket may cause an electrical short, increasing the risk of fire.
Pilgrim's Pride is recalling ready-to-eat breaded chicken patties that may contain rubber. The recall affects approximately 101,310 pounds shipped to institutions nationwide.
Rural King is recalling electric heated blankets and throws because the cords can overheat, posing fire and burn risks. Consumers should stop using the products and contact the company for a refund.
Daimler Vans USA is recalling 2016-2017 Mercedes-Benz Sprinter 2500 and 3500 vans with folding seats because the unloaded vehicle weight label may be incorrect, increasing crash risk.
Specialized Bicycle Components is recalling about 5,550 2018 Allez road racing bicycles in the U.S. because the fork can break, posing a crash hazard.
Jaguar is recalling 2018 XF Sportbrake vehicles because incorrect air bag calibration may cause improper deployment in low-speed crashes, increasing injury risk.
AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection because one vial contained a piece of glass.
Brenckle Farms is recalling fresh cilantro from Hartville, Ohio, after being notified that the product contains Listeria monocytogenes.
Panera, LLC is recalling Chive & Onion Reduced Fat Cream Cheese Spread due to potential Listeria monocytogenes contamination.
Bulletproof 360 Inc is recalling Unflavored Collagen Protein because the product contains undeclared milk. The item is mislabeled as collagen protein but actually contains whey protein.
Productos Pacheco, Inc. is recalling Vanilla Cake with Cheese due to undeclared allergens including wheat, soy, milk, and food dyes.
Panera is recalling Reduced-Fat Honey Walnut Cream Cheese due to potential Listeria monocytogenes contamination. The product was sold nationwide at Panera Cafes.
AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL because white particulate matter identified as mold was found in one bag.
Productos Pacheco, Inc. is recalling Polvorones NET WT 4OZ due to undeclared soy and wheat allergens. The product was distributed to consignees in Puerto Rico.
Aurobindo Pharma is recalling 53,040 vials of Ampicillin and Sulbactam for Injection due to a confirmed report of visible glass particulate matter.
Panera, LLC is recalling Plain Cream Cheese in 2 oz. and 8 oz. sizes due to potential Listeria monocytogenes contamination. The product was sold nationwide at Panera Cafes.
Panera, LLC is recalling Reduced-Fat Wild Blueberry Cream Cheese because it may be contaminated with Listeria monocytogenes. The product was sold nationwide at Panera Cafes.
Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules because they were marketed without an approved NDA/ANDA, constituting misbranding and unapproved new drugs.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Intrathecal Compounding Specialist, LLC is recalling sterile morphine sulfate preparations compounded between October 16 and November 17, 2017, due to a lack of sterility assurance.
Flawless Beauty LLC is voluntarily recalling Tatiomax Glutathione Whitening kits nationwide because the products were marketed without FDA approval.
Looking for a different month? Back to 2018.