Archive
426 recalls were announced in May 2022.
Of the 426 recalls this month scored against our rubric, 3% are Critical, 16% are Severe.
Which agencies issued them
Hyundai is recalling 2013-2014 Sonata vehicles because a low-pressure fuel hose may crack and leak, increasing the risk of a fire.
Continental Tire is recalling specific motorcycle tires because cracks in the tread grooves can lead to tread separation, increasing the risk of a crash.
Hyundai is recalling 2021-2022 Accent vehicles because a steering column bolt may not be properly secured. This can cause the steering column to detach, resulting in loss of steering control and increased crash risk.
Heartland is recalling certain 2022 Sundance trailers because the 12-volt breaker cover for the slide-out was not installed during production, exposing studs that may cause electrical arcing and fire.
Winnebago is recalling 2021-2022 Micro Minnie and Voyage travel trailers due to cracked LP gas fittings that may leak. Gas leaks near ignition sources pose a fire risk.
ElectraMeccanica is recalling 129 2021 Solo G3 vehicles because a rear turn signal failure may not alert the driver, increasing crash risk.
Grand Design RV is recalling certain 2022 Solitude, Momentum, Reflection, Imagine, and Transcend travel trailer models with cracked LP gas disconnect fittings that may cause gas leaks and fire risk.
Certain 2022 Toyota vehicles' load capacity labels may fade and become illegible. Illegible labels could allow vehicle overloading, increasing crash risk.
A bolt in the steering column may not be secured properly in certain 2021-2022 Kia Rio and Forte vehicles, potentially causing the steering column to detach from the steering rack and result in loss of steering control.
Highland Ridge RV is recalling 2021-2022 Mesa Ridge and Open Range trailers because cracked LP gas fittings may leak gas, increasing fire risk.
Thor Motor Coach is recalling certain 2022-2023 recreational vehicles due to cracked LP gas system fittings that may leak and increase fire risk. Dealers will replace the fittings free of charge.
Starcraft RV is recalling 2022 Super Lite and Super Lite Maxx travel trailers because cracked quick disconnect fittings in the LP gas system may cause a gas leak.
Weldon Division of Akron Brass is recalling 860 electrical multiplex modules due to an extra resistor that can cause vehicle lighting to fail.
Winter Water Factory is recalling about 46,500 infant jumpsuits, rompers, snap suits, dresses and bibs because snaps can detach and expose sharp prongs, posing choking and laceration hazards to young children.
WizWheelz is recalling about 340 GreenSpeed Magnum and Magnum XL recumbent trikes because the front axles may come loose during use, causing riders to lose control and crash.
Linum Home Textiles is recalling about 44,600 children's cotton robes because they fail to meet federal flammability standards for children's sleepwear, posing a burn injury risk.
Jayco is recalling 838 Seismic, Pinnacle, and Northpoint fifth wheel travel trailers from 2021-2022 due to cracked LP gas quick disconnect fittings that may leak, creating a fire risk.
NewCosplay children's robes fail to meet flammability standards for sleepwear, posing a risk of burn injuries to children. Approximately 3,160 units were sold online from December 2021 through March 2022.
About 300 BIBS Baby Glass Bottles sold nationwide are being recalled because hot liquids can cause the rubber bumper to shrink, making the bottle tilt and spill, posing a burn hazard.
Santa Cruz Bicycles is recalling about 1,600 of its 2022 Heckler 9 electric bicycles because the battery latch mechanism can malfunction, causing the battery to fall off the frame and posing a fall hazard to riders. The latch spring can also wear the battery housing over time, creating a fire hazard.
Barcelona Vinaigrette Grain Bowls by Produce Packaging Inc. are recalled because the label does not declare wheat content. This poses a risk to consumers with wheat allergies.
Mylan Pharmaceuticals is recalling 89,665 vials of Insulin Glargine Injection (100 units/mL) due to missing labels on the vials. Affected patients should not use the product and should contact their healthcare provider.
Suave 24-Hour Protection Aerosol Antiperspirant has been recalled nationwide due to the presence of benzene. The recall affects 4 oz. and 6 oz. cans bearing expiration date 9/30/2023.
Produce Packaging Inc.'s Spicy Southwest Grain Bowl is recalled for failing to declare wheat on the product label. Products were distributed to Illinois and Ohio.
Groundwork Coffee LLC recalled MIND-FULL Bar snacks distributed in California and Oregon because allergens were not properly declared on the product. The bars contain peanut butter and should not be consumed by those with nut allergies.
Produce Packaging Inc. is recalling 57 cases of Red Curry Grain Bowls distributed to IL and OH due to undeclared wheat on the product label. The FDA issued a Class I classification for this recall.
Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.
Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.
The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.
World Variety Produce Inc is recalling Organic Marketside Zucchini sold at Walmart due to potential Salmonella contamination. The product was distributed to Walmart distribution centers in 18 states.
Olympia Compounding Pharmacy is recalling QM-4, a compounded injectable, for manufacturing control deviations. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.
Jayco is recalling 2020-2022 Precept motorhomes because the heat shield beneath the storage compartment may be too short, allowing exhaust heat to melt it and increase fire risk.
Brake caliper mounting bolts may loosen or detach on certain 2022-2023 Western Star 47X and 49X trucks, reducing brake performance. Dealers will inspect and tighten the bolts free of charge.
Olympia Compounding Pharmacy is recalling 2,201 vials of RE-2, a compounded injectable medication, because environmental and personnel monitoring deviations were not properly investigated prior to October 2021.
Kalmar is recalling 2015-2022 Ottawa T2 terminal tractors because the trailer parking brake may set unexpectedly, increasing crash risk.
Olympia Compounding Pharmacy recalls SB-6 injectable drug due to manufacturing deficiencies. Prior to October 2021, environmental and personnel monitoring procedures were not properly investigated.
Elegant Foods is recalling Raspberry Sorbet because the label does not declare whey protein concentrate as a milk allergen. Consumers with milk allergies could experience a serious allergic reaction if they consume this product.
Elegant Foods strawberry sorbet in Wisconsin is being recalled because the label fails to identify whey protein concentrate, a milk derivative, as milk. This poses a risk to consumers with milk allergies.
Olympia Compounding Pharmacy is recalling 388 vials of BIMIX-3 injection due to manufacturing process failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021, raising concerns about product quality.
Siemens is recalling 31 Acuson 9vE4 ultrasound transducers that may exceed thermal index limits, creating a potential risk of thermal injury. Affected units were distributed in US states and international locations.
Elegant Foods is recalling Mandarin Orange Sorbet because whey protein concentrate in the stabilizer is not identified as milk on the label. Consumers with milk allergies may be at risk.
Rebel Creamery is recalling Rebel Pistachio Ice Cream (lot code 05522, best by 02/24/24) because it may contain pistachio shell fragments, posing a choking hazard.
Elegant Foods is recalling its Blackberry Sorbet because the label fails to identify whey protein concentrate as a milk ingredient, posing a risk to consumers with milk allergies.
Ferrero USA is recalling Kinder Mix Chocolate Treats Baskets (5.3 oz) due to possible contamination with Salmonella Typhimurium. Affected product was distributed to retail stores across 19 states.
Ferrero USA Inc is recalling 71,280 units of Kinder Happy Moments chocolate and crispy wafers assortment due to possible Salmonella Typhimurium contamination. No illnesses have been reported.
The FDA is recalling Formula F9, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring protocols were not properly followed, which could allow contamination.
Olympia Compounding Pharmacy recalls 1110 vials of SB-5 injectable (nationwide) due to failure to properly investigate environmental monitoring deviations prior to October 2021. No illnesses reported.
Olympia Compounding Pharmacy is recalling 525 vials of ST-1, a prescription injectable medication, due to manufacturing control failures.
Olympia Compounding Pharmacy is recalling T-105 injectables nationwide due to manufacturing process deviations. Environmental and personnel monitoring failures prior to October 2021 were not properly investigated.
Olympia Compounding Pharmacy is recalling a multi-drug injectable product nationwide due to manufacturing control deviations. The facility failed to properly investigate environmental and personnel monitoring excursions prior to October 2021.
Olympia Compounding Pharmacy recalls Testosterone Cypionate vials nationwide due to deviations in manufacturing quality monitoring procedures prior to October 2021.
Olympia Compounding Pharmacy is recalling T-101, an injectable medication distributed nationwide, due to manufacturing quality control deviations in environmental and personnel monitoring prior to October 2021.
Olympia Compounding Pharmacy recalled PGE-3 Alprostadil 150 mcg/mL injection due to manufacturing facility failure to properly investigate environmental and personnel monitoring excursions.
Olympia Compounding Pharmacy is recalling NAD+ powder vials nationwide because they fail to reconstitute properly. Affected lot F41116 has a beyond-use date of 6/16/2022.
Olympia Compounding Pharmacy is recalling 2005 vials of ST-2, a compounded pharmaceutical, nationwide due to manufacturing practice deviations and failures to properly investigate environmental and personnel monitoring excursions.
Preferred Pharmaceuticals is recalling Losartan Potassium 50mg tablets due to AZIDO impurity levels exceeding acceptable limits. The affected product was distributed to California, Indiana, and Florida.
Olympia Compounding Pharmacy is recalling AT-6 injectable drug due to manufacturing facility control failures. Environmental and personnel monitoring deviations were not properly investigated prior to October 2021.
Freudenberg Medical is recalling the Empower Introducer Sheath due to defective adhesive on the catheter shaft that could cause blood clots and tissue damage.
FDA recalls Boston Scientific's SpaceOAR System due to risk of embolism from incorrect hydrogel placement during prostate cancer radiotherapy. Updated instructions provide verification steps for proper placement.
The SpaceOAR Vue System implant used in prostate cancer radiotherapy is being recalled because improper hydrogel placement can cause embolism. Boston Scientific has updated instructions and warnings to prevent misplacement.
ROi CPS LLC is recalling 1,501 convenience kits containing regard IV Start Kits due to inadequate validation of manufacturing test methods. Products were distributed in Missouri.
Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.
Olympia Compounding Pharmacy is recalling NB-243, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.
Olympia Compounding Pharmacy recalls 6,431 vials of Hydroxocobalamin B12 injection nationwide due to manufacturing quality control failures. Environmental and personnel monitoring systems prior to October 2021 did not properly investigate deviations from acceptable limits.
Olympia Compounding Pharmacy is recalling NAD+ lyophilized powder (16,329 vials nationwide) due to failure to properly investigate environmental and personnel monitoring violations in manufacturing.
Olympia Compounding Pharmacy is recalling AT-1 injectable medication due to manufacturing control violations. Environmental and personnel monitoring failures may have affected product quality.
Olympia Compounding Pharmacy recalls 1,871 multi-dose vials of QM-2 injectable medication due to failure to properly investigate manufacturing monitoring excursions prior to October 2021. No illnesses reported.
Olympia Compounding Pharmacy recalls 1,679 vials of QM-3 injection medication nationwide due to failures in environmental and personnel monitoring during manufacturing.
Olympia Compounding Pharmacy is recalling 4,521 vials of Phenylephrine 1 mg/mL due to manufacturing quality control failures. Environmental and personnel monitoring procedures were not properly investigated prior to October 1, 2021.
Olympia Compounding Pharmacy is recalling T-106 injectable drug nationwide (4,129 vials) due to manufacturing control deviations. Environmental and personnel monitoring failures prior to October 2021 were not properly investigated.
Olympia Compounding Pharmacy is recalling SB-4 due to manufacturing quality control failures. The company did not properly investigate environmental and personnel monitoring problems that occurred before October 2021.
Olympia Pharmacy has recalled 45,935 vials of pharmaceutical diluent due to manufacturing compliance deviations. Environmental and personnel monitoring limits were exceeded and not properly investigated prior to October 2021.
Unilever is recalling all lots of Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent nationwide due to potential benzene contamination at the manufacturing facility.
RemedyRepack Inc. is recalling Losartan Potassium 50 mg tablets due to CGMP deviations with azido impurity levels above acceptable limits. The affected lots were distributed to customers in Alaska and Pennsylvania.
Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication, due to CGMP deviations in environmental and personnel monitoring. Monitoring excursions were not properly investigated prior to October 2021.
Torco Race Fuels hand sanitizer is being recalled because FDA analysis found acetaldehyde and acetal above specification limits. The product was distributed in the USA.
Olympia Pharmaceuticals is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide due to manufacturing quality control deviations in which monitoring excursions were not properly investigated. Patients should contact their healthcare provider.
Teva Pharmaceuticals initiated a voluntary recall of Lidocaine-Prilocaine Cream due to manufacturing practice violations. The recall affects 353,964 units distributed nationwide.
Stryker GmbH recalls 246 Smart Toe II orthopedic implants due to label obstruction that obscures the nickel-sensitivity contraindication, potentially allowing inappropriate use.
Drager is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a temporary loss of central monitoring functionality. The software is used for patient monitoring with wireless telemetry devices.
Siemens Healthcare is recalling IMMULITE 2000 hCG diagnostic systems due to potential sample carryover that could produce falsely elevated hCG test results.
Carl Zeiss Meditec is recalling the ZEISS miLOOP Lens Fragmentation Device due to high friction in the slider mechanism that may cause it to stick or fail to move as intended during cataract surgery.
Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.
Instrumentation Laboratory recalls ACL TOP coagulation analyzers due to potential carryover contamination that may cause inaccurate anticoagulation test results. When specific reagents are used together, tests for heparin, apixaban, and rivaroxaban may show elevated results.
The PrisMax System may revert custom treatment parameters to default values without notifying the operator when the Same Patient function is used. This could cause patients to receive unintended treatment settings.
The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.
Freudenberg Medical is recalling Empower Introducer Sheath devices (Model 668782-200) due to potential adhesive residue inside the catheter shaft that may cause blood clots and tissue damage. Affected devices were distributed in the US and Netherlands.
The InterStim X Clinician software used to program urinary incontinence therapy has a software bug that causes patient information to be lost and display a 'Data Lost' notification.
Waters Medical Systems LLC is recalling WAVES WCM Kidney Cassette Modules due to a potential for the pump head to leak solution. The recall affects medical facilities in Tennessee and France.
Sight Sciences is recalling 921 TearCare version 1.0 SmartHubs ophthalmic devices distributed nationwide because they were distributed prior to FDA 510(k) clearance without premarket evaluation of their performance characteristics.
Roche Diabetes Care Platform Software version 2.5.2 may display incorrect patient data when users navigate between patient records using the browser back button. No illnesses have been reported.
The PrisMax dialysis system has a software bug that silently reverts treatment parameters to default values without notifying operators, affecting 1,253 units worldwide.
Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.
NeuMoDx Molecular is recalling diagnostic cartridges used in COVID-19 and flu/RSV tests because of potential for false positive SARS-CoV-2 results, which could lead to incorrect patient management.
Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.
Elegant Foods Cherry Sorbet is being recalled because the label fails to identify whey protein concentrate in the stabilizer as containing milk, creating a risk for consumers with milk allergies.
Elegant Foods is recalling blueberry sorbet because the label fails to identify whey protein concentrate in the stabilizer as a milk allergen, posing risk to consumers with milk allergies.
Elegant Foods, LLC is recalling its 5# Lemon Curd product distributed in Wisconsin due to a missing ingredient label that fails to disclose eggs, a major food allergen.
Elegant Foods recalls Blood Orange Sorbet because the label fails to identify whey protein concentrate as milk. Consumers with milk allergies risk allergic reaction if they consume this product.
Elegant Foods is recalling Mango Sorbet because the label does not identify whey protein concentrate, a milk source, in the stabilizer. Consumers with milk allergies should not consume this product.
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