Archive
513 recalls were announced in June 2023.
Of the 513 recalls this month scored against our rubric, 3% are Critical, 36% are Severe.
Which agencies issued them
Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.
DIBE LLC is recalling TETAS Mireya, SABOR Nutella chocolate spread due to undeclared soy allergen. Consumers with soy allergies should not consume this product.
DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.
Procaps is recalling Bacaolinita Liquid Dietary Supplement (8 fl oz bottles) because PEG-40 was not declared on the product label. Consumers should discontinue use.
C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.
HF Acquisition Co LLC is recalling Glycopyrrolate Injection 0.2mg/mL due to a label mix-up affecting specific lots distributed in Texas, Arizona, and California.
RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.
Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.
Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.
Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.
Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.
Blue Bird is recalling 2022-2024 All American transit buses because a software error may prevent air pressure gauges and low air warnings from functioning, increasing crash risk.
Blue Bird is recalling 2021-2024 All American and 2021-2022 Vision school buses because a software error may prevent air pressure warnings from functioning, increasing crash risk.
PACCAR is recalling 2021-2023 Peterbilt 579 trucks with MX-13 engines because an improperly installed fastener can chafe the alternator cable, increasing fire risk.
Tesla is recalling 2023 Semi trucks because the door warning system allows drivers to dismiss alerts about unlatched doors, increasing injury risk.
The 2022 Nissan Sentra may have a defective driver's side cowl seal, allowing water intrusion and electrical corrosion. This could cause loss of airbag function, exterior lighting, and braking safety features, increasing crash and fire risk.
J.T.M. Provisions is recalling approximately 200 pounds of ready-to-eat Homestyle Chili Topping because it may contain beef taco filling with undeclared soy.
East Penn is recalling Deka 648MF batteries because an incomplete electrical connection may cause sparks, increasing the risk of injury.
Ford is recalling 2022-2023 F-150 Lightning vehicles because microcracks in the rear lightbar lens can cause reverse lights to fail or flicker.
SAF-Holland is recalling CBXA40 and ULX40 suspension systems with Tire Pilot Plus management systems because all eight tires may lose pressure at speeds over 45 mph.
Ford recalls 2018-2023 Expedition, Navigator, and F-Series vehicles lacking head restraint adjustment instructions. Improper adjustment increases crash injury risk.
Chrysler is recalling 2014-2020 Jeep Grand Cherokee and 2014-2019 Ram 1500 vehicles with 3.0L Diesel engines because a sensor defect may cause the engine to stall, increasing crash risk.
Chrysler is recalling certain 2022-2023 Jeep Grand Cherokee and 2021-2023 Jeep Grand Cherokee L vehicles. Rear coil springs may detach while driving, creating a crash risk; dealers will repair them free.
Autocar is recalling 2022-2023 Legend vehicles because the steering column shaft may not be properly welded, which could cause a loss of steering control.
Altec is recalling 2022-2023 TG-124S trailers because axle U-bolts may loosen and detach, increasing crash risk. Owners should contact Altec for a free inspection and tightening.
Bell Sports is recalling about 15,000 Giro Merit bicycle helmets because they do not meet federal safety standards and can fail to protect in a crash, risking head injury. Consumers should stop using them and contact Giro for a free replacement or refund.
Deux Par Deux children's one-piece and two-piece pajama sets fail to meet federal flammability standards for children's sleepwear, posing a burn hazard. About 90 units sold online from January to February 2023 are affected.
Certain 2023 Hyundai Palisade vehicles have a brake booster defect that can cause loss of power brake assist, requiring longer stopping distances and increasing crash risk.
Allied Air Enterprises is recalling about 9,255 Armstrong Air and Air Ease single-stage gas furnaces sold between September 2022 and March 2023 due to improper component assembly that can cause the furnace to produce high levels of carbon monoxide.
Textron Specialized Vehicles is recalling about 8,350 Arctic Cat 8000 Series Snowmobiles because the fuel rail dampener snap ring can become loose, leak fuel, and create a fire hazard. Consumers should stop using the snowmobiles immediately and contact the manufacturer for a free inspection and repair.
Ashley Furniture is recalling about 253,000 Party Time power loveseats, sofas, and recliners because the LED cupholder can overheat and cause fire. Consumers should unplug the units and contact the company for a free repair.
TJX is recalling about 10,850 Haining Degao Benches because the legs can break or detach when someone is seated, creating a fall hazard. The company has received 21 reports of legs breaking or detaching at stores, including 17 reports of injuries.
Uniek is recalling Kate and Laurel Astora and Valenti mirrors because the mirror glass can detach from the frame and fall, posing a laceration hazard. No injuries have been reported.
Little Cotton Clothes children's pajamas and nightdresses fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 550 units were sold online and in children's clothing stores from September 2022 through January 2023.
TopGlore is recalling about 650 Narskido infant bath seats sold on Amazon because they fail to meet federal safety standards and can tip over, posing a drowning hazard to babies.
Chrysler is recalling 2022 Jeep Grand Cherokee 4XE vehicles because a software issue may cause the engine to shut down, increasing crash risk.
BMW is recalling 2023 740i, 760i, and i7 vehicles because front seat length adjustment systems may not be welded properly, increasing injury risk in a crash.
John Deere is recalling about 1,600 XUV590E, XUV590M, and XUV590M S4 Gator utility vehicles because fuel can leak from under the fuel cap, creating a fire hazard. No injuries have been reported.
Living Nutz Nut & Seed Butter products have been recalled due to potential Salmonella contamination. The recall affects 68 units distributed across seven states.
Bean sprouts produced by Chang & Son Enterprises, Inc. are recalled due to potential Listeria monocytogenes contamination. Affected products include 10-pound bags and 12-ounce packages with sell-by dates before May 28, 2023.
AH USA Group Inc is recalling Black Fungus Golden Koi 2.5 oz packages due to potential salmonella contamination. The product was distributed across 19 states.
SunOpta Grains and Foods Inc. is recalling Organic Pineapple Chunks due to potential Listeria monocytogenes contamination. Affected lots 8FQ229702000MX and 8FQ229802000MX were distributed in Oregon.
G-SUPRESS DX pediatric drops are being recalled due to a product mix-up: an incorrect product was found inside some cartons in Puerto Rico. The recall affects 9,077 bottles (Lot D20911, expires Oct/25).
Nissan is recalling driver-side powered seat cushion frames for certain 2021-2023 Rogue, Pathfinder, and INFINITI QX60 vehicles because the seat may not be fully secured, increasing injury risk in a crash.
Nature's Wonder Premium Soybean Sprouts are recalled due to potential Listeria monocytogenes contamination. Affected products (12 oz bags, UPC 815098001347) were distributed in seven states; discard or return if purchased.
Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required stability studies.
Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.
Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.
Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL) nationwide. The recall was issued because the firm ceased operations and could not complete required stability studies as mandated by manufacturing regulations.
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.
Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.
The H.T. Hackney Company is recalling Fresh location Caesar Salad over potential metal contamination. Affected products were distributed in four states with a 'Fresh by' date of 5/19/2023.
Akorn recalled all lots of Megestrol Acetate Oral Suspension nationwide due to the firm's inability to complete required stability studies after ceasing operations.
Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.
Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.
Maquet is recalling QUADROX-i Adult cardiopulmonary bypass oxygenators (Models HMO 70000-USA and HMO 71000-USA) due to packaging defects including holes, cracks, and improper placement of accessories that may compromise sterility.
Denison Pharmaceuticals recalls Pin-Away Pyrantel Pamoate pinworm treatment nationwide due to CGMP deviation: non-food-grade lubricant used in the manufacturing mixing vessel.
Origami Catering has recalled Multigrain Spicy Salmon Avocado Roll products due to an undeclared sesame allergen. Sesame seeds are visible on the product but sesame is not listed in the allergen declaration statement.
Kia is recalling certain 2023 Sportage vehicles where the brake booster diaphragm may become misaligned, causing a loss of power brake assist and extending vehicle stopping distance.
Akorn, Inc. is recalling all lots of Midazolam Injection USP 2mg/2mL nationwide because the manufacturer went out of business and cannot complete required stability studies mandated by Current Good Manufacturing Practice regulations.
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators due to packaging defects that may compromise the sterile barrier, risking infection and other serious complications.
Maquet is recalling QUADROX-i Adult Oxygenators used in cardiopulmonary bypass surgery due to packaging defects that may compromise the sterile barrier. Contact with non-sterile devices could cause infection, sepsis, or ischemia.
BMW is recalling 2022-2024 iX vehicles because cruise control may unintentionally reactivate when turning the steering wheel at low speeds, increasing the risk of unintended acceleration and crashes.
Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution 0.3% because the manufacturer went out of business and could not complete required stability studies, a violation of manufacturing regulations.
All lots of Trihexyphenidyl Hydrochloride Oral Solution (2mg/5mL) distributed nationwide have been recalled. The manufacturer went out of business and could not complete stability studies needed to verify the drug's safety over time.
FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct stability studies.
Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.
Garden Highway Atlanta is recalling approximately 1,147 turkey and havarti sandwiches because sesame was not declared on the product label. The undeclared allergen poses a risk to consumers with sesame allergies.
Vital Proteins is recalling 59,701 canisters of Collagen Peptides (24oz, UPC 8 57273 00866 6) due to potential contamination from broken plastic lid pieces. Affected products have lot code 30095993HA with Best By date 01-09-2028.
Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.
Maquet Medical Systems USA recalls 24,250 QUADROX-iD Adult Oxygenators due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices during cardiopulmonary bypass surgery.
Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices due to damaged packaging that may compromise sterility. This could result in infection, sepsis, or ischemia.
Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment because the packaging contains the opposite side of the implant. This error could result in implantation of the wrong component if not detected.
Teleflex LLC is recalling approximately 146,606 units of HORIZON Microclip Titanium Ligating Clips because a safety feature is missing from the clip cartridge. Without this step feature, clips may be positioned variably and applied inadequately to blood vessels during surgery.
Philips Azurion X-ray imaging systems may suddenly lose X-ray functionality when disk storage capacity is reached, potentially interrupting medical procedures.
Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.
Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.
Medline Industries is recalling three sterile surgical procedure packs that were damaged by water, compromising their sterility. The recall affects 342 packs distributed in California.
Philips is recalling 1,421 EarlyVue VS30 Vital Signs Monitor units in the U.S. because a missing calibration alarm can cause inaccurate CO2 measurements and failure to detect critical patient condition changes.
Maquet Medical Systems is recalling Venous Hardshell Cardiotomy Reservoirs because packaging pinholes may compromise the sterile barrier, potentially exposing patients to non-sterile devices that could cause infection or sepsis.
The H.T. Hackney Company is recalling Fresh Location Chef Salad with Ranch due to the potential for metal in the product. No illnesses have been reported.
Akorn, Inc. is recalling all lots of Amantadine Hydrochloride Oral Solution (50mg/5mL) nationwide due to inability to complete required stability studies following the firm's closure, resulting in manufacturing quality deviations.
Akorn, Inc. has recalled all lots of Neomycin & Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment due to inability to complete required stability studies following the firm's business closure.
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of infection, sepsis, or ischemia.
Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution 2% due to manufacturing deviations that prevented completion of stability studies. The product was distributed nationwide in the USA and Puerto Rico.
Akorn, Inc. recalled all lots of Gonak Hypromellose Ophthalmic Solution distributed in the USA and Puerto Rico after the firm ceased operations and could not complete required stability studies.
Smith & Nephew is recalling 2,146 cementless partial knee implants (ENGAGE system) due to complaint data showing higher-than-expected revision rates compared to similar devices.
Akorn, Inc. is recalling all lots of Calcipotriene Topical Solution 0.005% due to manufacturing compliance failures and incomplete stability studies. The manufacturer ceased operations before completing required stability tests.
The H.T. Hackney Company is recalling Fresh location Turkey Caesar Salad (7.5 oz) due to potential metal contamination. The product was distributed in Illinois, Indiana, Michigan, and Ohio.
Maquet Medical is recalling QUADROX-iR oxygenators used in heart-lung bypass procedures due to potential pinholes in packaging that may compromise the sterile barrier, creating risk of serious infection.
Trader Joe's Instant Cold Brew Coffee may contain glass particles. Regal Trading is recalling 14,112 cases distributed in eight states. No illnesses have been reported.
Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.
Akorn Inc. recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 1% nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies.
Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg due to manufacturing deviations and inability to verify product stability.
The H.T. Hackney Company is recalling Fresh Location Garden Salad with Ranch due to potential metal fragments in the product, which may pose a choking and injury risk.
Akorn recalled all lots of Calcitriol Injection 2 mcg/mL nationwide due to CGMP deviations and inability to complete stability studies after the firm went out of business.
QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.
Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.
Akorn, Inc. is recalling all lots of Clobetasol Propionate Ointment 0.05% due to manufacturing practice violations and inability to complete required stability studies. Product was distributed nationwide in the USA and Puerto Rico.
Smith & Nephew has recalled 1,994 units of its ENGAGE Cementless Partial Knee System because recent data shows higher-than-expected revision rates compared to similar devices.
Looking for a different month? Back to 2023.