Archive
518 recalls were announced in October 2021.
Of the 518 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.
Which agencies issued them
Suntree Snack Foods is recalling Lightly Salted Cashews Halves & Pieces (40 oz., UPC 842379195358) because the product may contain glass pieces. Consumers should not eat the product and should contact the firm or discard it.
Suntree Snack Foods is recalling Roasted Lightly Salted Cashew Halves and Pieces (8 oz. bags) because some packages contain glass pieces. Consumers should not eat the product.
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Chocolate and the Chip is recalling Original Nutella Cookie Cake due to undeclared allergens (wheat, milk, soy, and tree nuts) found during a California Department of Public Health inspection. The product was distributed nationwide.
GE Healthcare is recalling Optima MR450w 1.5T MRI systems due to a software issue in version DV29.1 that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.
Implant Resource Inc is recalling the MPR Slotted Mallet (Model MPR-1120-1000, Lot 200911-1-1) due to potential separation of the mallet head from the handle and unexpected deformations on the striking surface.
Lake Wolf Creamery is recalling Queso Fresco cheese because pasteurization temperature was not properly recorded and required air space temperature controls were not maintained during production.
ADRIA SRL is recalling herniatome surgical devices used in lumbar spinal procedures due to improper sterilization. The contract sterilizer failed to follow required process parameters, potentially compromising device sterility.
Suntree Snack Foods is recalling Mountain Trail Mix 44 oz. packages because a customer reported finding glass pieces in the product.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.
Teva Pharmaceuticals is recalling approximately 5,500 units of AirDuo Digihaler 232/14 inhalation powder distributed nationwide because some inhalers contain less salmeterol than the labeled dose.
Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.
Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.
Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to manufacturing practice deviations. Approximately 36,660 cans were distributed nationwide.
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some units contain less salmeterol than the labeled dose. The affected sample batch was distributed nationwide.
Dr. Reddy's Laboratories is recalling Acid Reducer (Omeprazole Magnesium) 20 mg capsules nationwide because staples have been found co-mingled with capsules in bottles.
American Health Packaging is recalling GlipiZIDE Extended-Release Tablets 2.5 mg (Lot #194141) nationwide because dissolution test results exceeded specification, which may affect the drug's effectiveness.
Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.
Beiersdorf Inc. is recalling 14,748 cans of Coppertone Pure & Simple baby 50 Sunscreen Spray due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide.
Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.
Beiersdorf Inc. is voluntarily recalling Coppertone Pure & Simple kids 50 Sunscreen Spray due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 70,320 cans distributed nationwide.
Piramal Critical Care is recalling Rocuronium Bromide Injection because the finished product vial lacks the required "WARNING: PARALYZING AGENT" statement on the flip cap. The missing warning could lead to unsafe use of this prescription neuromuscular-blocking drug.
5.11 Inc. is recalling about 45,170 Tactec Plate Carriers (style 56100) because the cable in the quick release system can separate from the handle, preventing swift removal in an emergency. No injuries have been reported.
Smith & Nephew is recalling 6.5mm x 165mm cannulated screws because the product label incorrectly states the screws are fully threaded when they are actually partially threaded.
Sanitor Corporation is recalling Cleaning Solutions Foaming Hand Sanitizer (Benzalkonium chloride 0.1%) due to contamination from Current Good Manufacturing Practice (CGMP) deviations. Use may cause skin or soft tissue infection and irritation.
Bard Peripheral Vascular Inc. is recalling 360 Jamshidi Bone Marrow Biopsy Trays (Catalog # BEK3411, Lot # 0001378561) due to misbranded labeling. The FDA classified this as a Class II recall affecting healthcare facilities in 16 U.S. states and Puerto Rico.
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.
Nissan is recalling 2017-2019 Rogue Hybrid vehicles because contact with the ECM bracket may damage the engine harness, causing a blown fuse and potential engine stall.
WABCO is recalling certain Trailer ABS Systems because improperly tightened screws may loosen, causing pressure loss and potential brake failure.
Navistar is recalling 2020-2023 IC Bus CESB school buses due to an engine control module defect that may cause unexpected engine shutdown while driving, increasing the risk of crashes and emergency evacuation situations.
Tesla is recalling certain 2020-2023 Model 3 vehicles because the side curtain airbag may be improperly secured to the roof rail and could twist, deploying incorrectly during a crash and increasing risk of injury or ejection.
Tesla is recalling 2019-2021 Model 3 and 2020-2021 Model Y vehicles where front suspension lateral link fasteners may loosen, potentially causing wheel misalignment and increasing crash risk.
Navistar is recalling 2020-2021 IC CE transit buses because a software fault may cause unexpected engine shutdowns, increasing crash risk.
Yamaha is recalling 2021 Tracer 9 GT motorcycles because the VIN on the certification label may not match the vehicle's stamped VIN, potentially preventing owners from receiving safety recall remedies.
Ferrari is recalling specific 458 and 488 models because the brake system may leak fluid, potentially causing a loss of braking ability.
Walmart is recalling Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones due to contamination with Burkholderia pseudomallei bacteria. CDC testing identified the hazard and is investigating a cluster of four melioidosis cases, including two deaths.
Forest River is recalling certain 2021-2022 XLR Toy Hauler recreational vehicles with a missing protective panel between the furnace and cargo area. The missing panel could allow cargo to contact furnace wiring, creating a fire hazard.
2022 Forest River XLR Toy Hauler RVs are recalled due to incorrect wiring lacking required over-current protection. The defect can cause electrical shorts and fire; dealers will replace the wiring and breaker at no cost.
Mercedes-Benz is recalling certain 2021 GLE and GLS models because the rear window may be insufficiently bonded, posing a road hazard risk.
Forest River is recalling 2022 Coachmen Catalina travel trailers because an unsealed panel between the furnace and cooktop could cause an inverted flame, increasing fire risk.
BMW is recalling certain 2022 X4 vehicles because the rear license plate may not be properly illuminated, violating federal safety standards and potentially creating visibility issues for other drivers.
Orange EV is recalling 2019-2021 T-Series electric trucks because a steering bolt may loosen, potentially causing loss of steering.
AFFCO USA is recalling approximately 24,461 pounds of frozen raw lamb shoulder products that were imported without the required re-inspection.
Lightform Inc. is recalling about 1,600 LF2 and LF2+ LED projectors because the fan can malfunction and overheat, posing a fire hazard. No injuries or property damage have been reported.
About 1,840 Husqvarna and GASGAS off-road competition motorcycles sold from May through August 2021 are being recalled because retaining clips on the front brake caliper can fall out, causing brake failure and crash hazard. No injuries have been reported.
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Ultrasound gels and lotions from National Distribution & Contracting Inc are being recalled due to potential bacterial contamination. About 25,103 units distributed nationwide and in Canada are affected.
Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.
FDA recalls ultrasound gels manufactured by Eco-Med Pharmaceutical due to possible bacterial contamination. Healthcare providers and facilities should stop use immediately.
Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.
Eli Lilly is recalling Glucagon Emergency Kits (Lot #D239382D, expiration April 2022) because some vials contain liquid instead of powder and do not deliver the full expected drug effect when administered.
Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.
Cuisine Innovations Unlimited, LLC is recalling Vemondo Vegan Crabless Mini Crabcakes sold at Lidl due to undeclared egg. The product may pose a risk to consumers with egg allergies.
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.
Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.
Doosan Portable Power is recalling 2019-2021 Mobile Generators and Air Compressors because improperly tightened wheel lug nuts could cause a tire to fall off, increasing crash risk.
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.
Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.
Elekta medical linear accelerators may have a defective diode that could fail destructively when removed, with risk of ejected debris. No injuries have been reported.
Green Field Farms Co-op is recalling chocolate milk products due to improper pasteurization. The affected products were distributed to Indiana, New Jersey, and Ohio.
Demaiz Inc. is recalling beef and pork tamales sold in Northern California because they contain sesame seeds, an allergen not listed on the label.
Kelly's Bakery Corp. is recalling Brownie Chocolate Walnuts because walnuts are not declared on the product label. Consumers with walnut allergies face a potential allergic reaction.
Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
Uoc Usa Inc recalls 3 United Orthopedics USTAR II knee components that fail to meet manufacturing specifications for concentricity and dynamic fatigue testing. These defects could affect implant performance.
Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.
Smiths Medical is recalling CBSS-5ML blood sampling system sets due to reported pressure shifts and incorrect pressure readings that may affect the accuracy of blood sample collection.
Elekta Medical Linear Accelerators may experience destructive diode failure with risk of ejected matter. Service personnel could be injured during component removal.
Litehouse Inc. is recalling Ranch dressing packaged in 1.25 oz. plastic cups because the product contains undeclared anchovies, a potential allergen not listed on packaging.
B&G Foods North America, Inc. is recalling Tone's Taco Seasoning Blend in plastic bottles because the product contains undeclared wheat, which poses a risk to consumers with wheat allergies.
Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.
Buurma Farms Inc is recalling Plain Parsley (Flat Parsley) bunches due to potential contamination with E. coli. The affected product was distributed to Michigan, Ohio, Illinois, New York, South Carolina, and Pennsylvania.
Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.
Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.
Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.
Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.
Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.
Draeger's Evita V500 ventilator software version 2.51 and lower may restart unexpectedly, briefly stopping ventilation and breathing support. 6,797 units are affected nationwide.
Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Centese Inc. is recalling Thoraguard Chest Tube Kits (20 Fr) because an adhesive joint in the SmartValve component can fail, causing fluid to leak. The affected kits were distributed to a single facility in California.
Dole Fresh Vegetables is recalling curly parsley distributed to five U.S. states due to potential non-O157 STEC (Shiga-Toxin 1) contamination. Consumers should not consume the affected product.
Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient results.
Customers of Philips HeartStart FRx defibrillators were not notified of previous recalls associated with various defibrillator models. This is a Class II medical device recall.
Flower Orthopedics Corporation is recalling 33 units of its 2.4mm Drill Bit Kit (Lot 2101321194) because the drill bits lack the AO connect feature, which may delay surgical procedures.
Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.
Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.
A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.
Smiths Medical has recalled its Medex closed blood sampling system due to pressure shifts and incorrect pressure readings. Approximately 13,620 units were distributed internationally.
The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.
W L Gore & Associates is recalling GORE VIABAHN VBX balloon expandable endoprosthesis units due to labeling showing incorrect device dimensions. Two units with specification mismatches were distributed to Italy and Lebanon.
Volkswagen Group is recalling certain 2021-2022 Audi vehicles due to a software error that may prevent the rear-view camera from displaying when reversing, potentially reducing driver visibility and increasing crash risk.
Sutphen is recalling one 2020 Fire Truck because improperly crimped lifting cables may detach, causing the generator set to fall and increasing injury risk.
Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect blood collection accuracy.
Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
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