Archive
482 recalls were announced in August 2021.
Of the 482 recalls this month scored against our rubric, 2% are Critical, 26% are Severe.
Which agencies issued them
Able Groupe Inc is recalling HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula because it was not submitted for required FDA pre-market notification and lacks mandatory English labeling statements.
Cocanu LLC is recalling Moonwalk 70% dark chocolate bars because milk is not declared on the label, even though lactose is present. The product may pose a risk to consumers with milk allergies.
Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.
Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.
Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.
Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.
Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.
Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.
T&R Enterprises USA, Inc. is recalling vegetable egg rolls because Yellow #5 dye is present in the product but not declared on the label. Consumers with allergies or sensitivities to Yellow #5 may be at risk.
Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.
Epimed International is recalling the NEO-KATH Caudal Set (REF 201-2430) because the stylet may protrude from the catheter's tip, potentially causing tissue injury. The recall affects 140 units distributed in the US and internationally.
Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.
Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.
Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.
W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.
229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.
Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.
Hitachi Healthcare is recalling 120 Model L43K intraoperative probes because the screw cover at the probe tip may fall off after cleaning and sterilization. Facilities should inspect probes before and after sterilization and before and after each surgical use.
Chicken of the Sea is recalling promotional Genova Meal Kits because products included in the kits were prepared in a home kitchen that did not meet quality standards.
Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.
Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.
DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.
Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.
High Performance Formulas is recalling Cholestene capsules (red yeast rice supplement, 1200 mg per 2 capsules, 120-count bottles) because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.
Teligent Pharma is recalling Econazole Nitrate Cream 1% in 85-gram bulk tubes due to incorrect labeling. The product was distributed nationwide.
Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.
Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula because required FDA premarket notifications were not submitted and products lack mandatory English labeling as required by federal regulations.
Dr. Reddy's Laboratories is recalling Tizanidine HCl 4 mg tablets nationwide because some tablets are shaved, failing the required tablet specification.
Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% due to a labeling mispack affecting Lot #16630 with expiration 03/2023. The recall was issued due to incorrect labeling on the product.
Wee Gallery is recalling Ocean and Safari animal wooden tray puzzles because the octopus and elephant puzzle pieces can break, posing a choking hazard to young children.
CB Distribution LLC is recalling Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice packages due to incorrect ingredient labeling. The product was distributed to distribution centers in Texas.
PL Custom is recalling 2019 Dodge RAM 5500 emergency vehicles because rear brake lines may wear, risking brake loss and crashes.
Willow Tree Poultry Farm is recalling approximately 52,022 pounds of chicken salads and dips that may contain hard white plastic. The products were distributed to nine northeastern states.
Crane Carrier is recalling 94 LET2 vehicles from 2020-2021 because a fuel hose may leak, increasing the risk of fire if exposed to an ignition source.
Dorel is recalling Maxi-Cosi Pria 85 convertible child seats because they may not adequately protect children from head injury if installed with only a lap belt.
Reitnouer is recalling 2017-2019 Steer Axle trailers because the steering arm may detach, potentially causing loss of control or road hazards.
Ford is recalling 2021 F-150 Super Cab vehicles because front seatbelt webbing may be incorrectly routed, increasing injury risk in a crash.
PL Custom is recalling one 2021 Ford E-450 emergency vehicle because its LCD display may freeze or fail, potentially delaying emergency efforts.
Ford and Lincoln are recalling certain 2021 Explorer and Aviator vehicles. Side air bag attachment weld studs may detach during deployment, potentially failing to provide proper protection in a crash.
General Motors is recalling certain 2016-2021 Chevrolet Malibu and 2019-2021 Cadillac XT4 vehicles because rear seat belt retractors may be improperly secured with loose or missing fasteners, potentially affecting safety in a crash.
General Motors is recalling 2020-2022 Chevrolet Bolt EV and 2022 Bolt EUV vehicles. The high-voltage battery could catch fire when charged to full or nearly full capacity, increasing risk of injury.
Volkswagen is recalling certain 2022 Taos vehicles because the underhood fuel supply quick-connector may detach from the fuel line, creating fuel leaks that increase risks of engine stalling and fire.
PACCAR is recalling certain 2021-2022 Peterbilt commercial trucks due to insufficient clearance in the Hill Start Assist valve assembly, which may damage the rear brake hose and disable rear braking. Dealers will inspect and repair the assembly free of charge.
Deere & Company is recalling approximately 200 John Deere compact utility tractors (models 4044M, 4044R, 4052M, 4052R, 4066M, 4066R) because rear wheel spacer bolts can be improperly torqued during manufacturing, causing the wheel to fall off and the tractor to overturn.
Space Craft is recalling Lippert 6400 series vented windows because the adhesive may fail, causing the vent to detach and increasing crash risk.
Frieyss infant bath seats fail to meet federal safety standards and can tip over while in use, posing a drowning hazard to babies. About 120 units were sold exclusively online at Amazon.com from March through April 2021.
Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.
Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.
Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.
Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.
McCormick & Company is recalling McCormick Perfect Pinch Italian Seasoning due to potential Salmonella contamination. Consumers should not consume the affected product.
Med Shop Total Care Inc. is recalling a Bupivacaine HCL-Lioresal PF injectable drug due to non-sterility concerns. The recall affects a 41 mL syringe product distributed in Texas and Puerto Rico.
Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot was distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. is recalling a 41 mL injectable drug combination due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
McCormick & Company is recalling Frank's Red Hot Buffalo Ranch Seasoning due to potential Salmonella contamination. The product was distributed to multiple U.S. states and Canada.
Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.
Slayer Forever, LLC (dba BUBS Naturals) is recalling BUBS Naturals MCT Oil Powder dietary supplement because the product contains undeclared milk allergens.
Med Shop Total Care Inc. is recalling Hydromorphone HCL-Bupivacaine HCL PF Injectable in 21 and 22 mL syringes in various strengths distributed in Texas and Puerto Rico due to non-sterility concerns.
DSD Merchandisers is recalling Dark Chocolate Malt Balls because some containers were filled with Dark Chocolate Peanut Butter malt balls instead, creating a risk for consumers with peanut allergies who may not be aware of the peanut content.
Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.
Ravin Crossbows is recalling white arrow nocks that can fail to engage properly with the bowstring, allowing the crossbow to discharge unexpectedly during re-nocking and causing finger injuries. About 220,000 units are affected.
Palfinger is recalling specific Knuckle Boom Cranes because the base may crack, potentially causing the crane to detach from the truck mount.
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
McCormick & Company is recalling McCormick Culinary Italian Seasoning (1.75 lbs. plastic jugs) distributed across multiple U.S. states and Canada due to potential Salmonella contamination.
Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.
IHERB LLC is recalling Solumeve Hydrolyzed Collagen Peptides dietary supplements because the MCT ingredient contains undeclared milk, which poses a risk to consumers with milk allergies.
Med Shop Total Care is voluntarily recalling injectable hydromorphone HCL-bupivacaine HCL-clonidine HCL due to non-sterility. The recall affects specific lots distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. is voluntarily recalling one lot of fentanyl-bupivacaine-baclofen injectable solution due to non-sterility concerns. The product was distributed in Texas and Puerto Rico.
Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes of multiple strengths due to non-sterility. The affected product was distributed to Texas and Puerto Rico.
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.
Med Shop Total Care Inc. is recalling a bupivacaine HCL-baclofen PF injectable drug (21 mL syringe, Lot #: 09282020@94) distributed in Texas and Puerto Rico due to non-sterility concerns.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
5000 Years Foods is recalling sliced cabbage kimchi products sold in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially reached customers nationwide through retail distributors.
Biomet is recalling Arcos hip prosthetic components that may develop corrosion and fail, potentially requiring revision surgery.
5000 Years Foods is recalling JULRADO Sliced Cabbage Kimchi in multiple container sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail distributors.
A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.
BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.
Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. No injuries have been reported.
Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.
Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.
5000 Years Foods is recalling NO MSG JULRADO SLICED CABBAGE KIMCHI in multiple sizes due to potential Listeria monocytogenes contamination. The product was distributed from Illinois to retailers potentially nationwide.
Hallmark is recalling approximately 15,500 wooden teether rings with plush attachments because the wooden ring can break into small parts, creating a choking hazard. The company has received four reports of the rings breaking, including one case where a child placed broken pieces in their mouth.
Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.
Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
Medline Industries is recalling 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.
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