September 2023 recalls

423 recalls were announced in September 2023.

What the numbers show

Critical: 4
Severe: 65
High: 298
Moderate: 54
Low: 2

Of the 423 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

Which agencies issued them

101–200 of 423

ModerateFDA (Devices)·Z-2592-2023·2023-09-27
Sentec Membrane Changer components recalled for manufacturing defect
SenTec AG recalls Membrane Changer components for the Sentec Digital Monitoring System due to a potential manufacturing defect that could affect measurement accuracy.
Product
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1533-2023·2023-09-27
HEB Easy Melt Salsa Queso Recalled Due to Conflicting Refrigeration Labels
HEB Easy Melt Salsa Queso is recalled for conflicting refrigeration labels that may cause improper storage. Over 7.2 million pounds were distributed across 32 states.
Product
HEB Easy Melt Salsa Queso, with Tomatoes, Jalapeno Peppers & Onions, Net Wt 32 oz (2 lbs) 907g. UPC 0 41220-33063 8. Refrigerate after Opening. Made with Pride and Care for H-E-B, San Antonio, Texas 78204
Category
Food
Distribution
32 states
ModerateFDA (Food)·F-1532-2023·2023-09-27
Refrigerated Cheese Products Recalled for Unclear Refrigeration Label Requirements
Great Lakes Cheese, Inc. is recalling refrigerated cheese products because product labels have varying refrigeration requirements that could lead to improper storage. Approximately 7.2 million lbs of products sold under Clancy's and Hill Country Fare brands are affected.
Product
Pasteurized Prepared Cheese Product, Queso Blanco, Half the Fat of Cheddar Cheese packaged under the following brands and sizes: 1. Clancy's CheeseMelt, Net Wt 32 oz (2 lbs) 907g. Refrigerate after Opening. Dist, & Sold exclusively by: Aldi, Batavia, IL 60510 2. Hill Cou
Category
Food
Distribution
32 states
ModerateFDA (Drugs)·D-1168-2023·2023-09-27
ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims
BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2622-2023·2023-09-27
COOLIEF RF Generator recalls due to F100 and F101 fault complaints
Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.
Product
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and
Category
Medical Device
Distribution
16 states
ModerateFDA (Food)·F-1529-2023·2023-09-27
Harris Teeter Cheesy Melt recalled for labeling refrigeration requirements
Harris Teeter Cheesy Melt pasteurized cheese product is recalled because labeling variations may prevent proper refrigeration. Approximately 7.2 million pounds are affected across 31 states with use-by dates of March 8, 2024 and earlier.
Product
Harris Tetter Cheesy Melt, Pasteurized Prepared Cheese Product, Net Wt 32 oz (2 lbs) 907g. UPC 0 72036-70682 9. After Opening, Refrigerate Up to 8 weeks. Do Not Freeze. Proudly Distributed By: Harris Teeter, LLC, Matthews, NC 28105
Category
Food
Distribution
32 states
ModerateFDA (Food)·F-1526-2023·2023-09-27
Refrigerated Cheese Products Recalled for Conflicting Label Instructions
Great Lakes Cheese is recalling multiple brands of refrigerated pasteurized cheese products due to conflicting refrigeration instructions on product labels. The conflicting label requirements could lead to improper storage.
Product
Pasteurized Prepared Cheese Product, packaged under the following brands and sizes: 1. Clancy's CheeseMelt, 1/2 Less Fat Than Cheddar Cheese, Net Wt 32 oz (2 lbs) 907g. Refrigerate after Opening. Dist, & Sold exclusively by: Aldi, Batavia, IL 60510 2. Dutch Farms Cheese M
Category
Food
Distribution
32 states
ModerateFDA (Devices)·Z-2590-2023·2023-09-27
Arrow ErgoPack PICC Catheters Recalled for Incorrect Product Labeling
Arrow International is recalling 190 units of Arrow ErgoPack One-Lumen PICC catheters (Lot 13F22J0617) because the product code and product name were incorrectly printed on the kit packaging. The units were distributed nationwide.
Product
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1525-2023·2023-09-27
Pasteurized Process Cheese Spread Recalled for Conflicting Refrigeration Labels
Great Lakes Cheese and related brands recalled 7.2 million pounds of pasteurized cheese spread due to conflicting refrigeration instructions on labels that may prevent proper storage.
Product
Pasteurized Process Cheese Spread packaged under the following brands and sizes: 1. Great Lakes Cheese Easy Cheesy, Net Wt 32 oz (2lb)907g. UPC 0 36514-19245 0. Refrigerate After Purchase. Distributed by Great Lakes Cheese Co., Inc. Hiram, OH 44234 2. HEB Easy Melt Queso B
Category
Food
Distribution
32 states
ModerateFDA (Drugs)·D-1172-2023·2023-09-27
Cequa cyclosporine ophthalmic solution recalled nationwide for subpotency
Sun Pharmaceutical is recalling Cequa (cyclosporine) ophthalmic solution because certain lots contain less active ingredient than specified. Contact your doctor if using an affected product.
Product
CEQUA — CEQUA (CYCLOSPORINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1527-2023·2023-09-27
Great Value Cheese Recall Due to Inconsistent Refrigeration Label Requirements
Great Value Melt'n Dip Easy Melt Cheese is being recalled due to inconsistent refrigeration labeling requirements that may result in improper storage. The product has a use-by date of 1/4/2024 or earlier.
Product
Great Value Melt'n Dip Easy Melt Cheese, Reduced Fat Pasteurized Prepared Cheese Product, Net Wt 32 oz (2 lbs) 907g. UPC 0 78742-01517 0. Refrigerate after Opening. Distributed By: Walmart Inc., Bentonville, AR 72716
Category
Food
Distribution
32 states
ModerateFDA (Food)·F-1530-2023·2023-09-27
HEB Easy Melt Pasteurized Cheese Spread Recalled for Conflicting Refrigeration Labels
Great Lakes Cheese is recalling HEB Easy Melt Original Pasteurized Process Cheese Spread because refrigeration instructions vary across product labels. No illnesses have been reported.
Product
Pasteurized Process Cheese Spread packaged under the following brands and sizes: 1. HEB Easy Melt Original, Net Wt 16 oz (1 lb) 453g. UPC 0 41220-73808 3. Refrigerate after Opening. Made with Pride and Care for H-E-B, San Antonio, Texas 78204 2. HEB Easy Melt Original, Net
Category
Food
Distribution
32 states
ModerateFDA (Food)·F-1531-2023·2023-09-27
Pasteurized Cheese Product Recalled for Inconsistent Refrigeration Instructions on Labels
Great Lakes Cheese, Inc. is recalling Hill Country Fare Melt'n Cheese because product labels contain inconsistent refrigeration requirements, which may result in improper storage by consumers.
Product
Hill Country Fare Melt'n Cheese, Pasteurized Prepared Cheese Product, Net Wt 32 oz (2 lbs) 907g. UPC 0 41220-77273 5. Refrigerate after Opening. Distributed By: H-E-B, San Antonio, TX 78204
Category
Food
Distribution
32 states
ModerateFDA (Food)·F-1539-2023·2023-09-27
Fox Confections Recalls Raspberry Truffles for Undeclared Food Dyes
Fox Confections is recalling F-Bombs Raspberry Truffles because they contain undeclared FD&C Yellow #5 and Yellow #6. The product was distributed to 90 retail locations in Illinois and Ohio.
Product
F-Bombs Raspberry Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018124
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-1524-2023·2023-09-27
Giant Eagle Cheese Spread Recalled Due to Inconsistent Refrigeration Labels
Giant Eagle Easy Melt cheese spread products have inconsistent refrigeration instructions on their labels. The varying label requirements may cause improper storage, creating potential food safety concerns.
Product
giant eagle Easy Melt, Pasteurized Prepared Cheese Spread. Net Wt 32 oz (2lb)907g. UPC 0 30034-06289 7. Refrigerate after Opening. Distributed by Giant Eagle, Inc., Pittsburgh, PA 15328-2809.
Category
Food
Distribution
32 states
ModerateFDA (Food)·F-1528-2023·2023-09-27
Refrigerated Pasteurized Cheese Products Recalled Due to Labeling Inconsistency
Great Value and SE Grocers refrigerated cheese products are being recalled because labels contain inconsistent refrigeration requirements, which may result in improper storage by consumers.
Product
Pasteurized Prepared Cheese Product packaged under the following brands and sizes: 1. Great Value Original Melt'n Dip Easy Melt Cheese, Net Wt 16 oz (1 lb) 453g. UPC 0 78742-01512 5. Refrigerate after Opening. Distributed By: Walmart Inc., Bentonville, AR 72716 2. Great
Category
Food
Distribution
32 states
LowFDA (Devices)·Z-2591-2023·2023-09-27
Arrow ErgoPack PICC catheter kits recalled for incorrect product labeling
Arrow International recalled 177 ErgoPack PICC catheter kits because the product code and name were incorrectly listed on the packaging. No illnesses or injuries reported.
Product
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
Category
Medical Device
Distribution
Distributed nationwide
SevereUSDA FSIS·046-2023·2023-09-25
USDA Recalls Ineligible Imported Pork Chicharrones from Honduras
Del Valle Import and Export is recalling 1,271 pounds of pork chicharrones imported from Honduras, a country ineligible to export pork to the U.S.
Product
Del Valle Import and Export, LLC, Recalls Ineligible Pork Chicharrones Product Imported From Honduras
Category
Food
Distribution
3 states
SevereNHTSA·23E070000·2023-09-25
Dexter Axle Recalls Goodride ST 200 Tires Due to Sidewall Separation Risk
Dexter Axle is recalling Goodride ST 200 tire and wheel assemblies because the sidewalls may bubble and separate, causing loss of tire pressure and increasing crash risk.
Product
TIRES:SIDEWALL recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V652000·2023-09-25
Kia Recalls Multiple Models Due to Electrical Short Fire Risk
Kia is recalling 1.7 million vehicles because an electrical short in the brake control unit may cause an engine compartment fire.
Product
KIA — KIA SORENTO, RIO, OPTIMA HYBRID, SOUL
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·045-2023·2023-09-23
Green Valley Foods Recalls Frozen Meat Pizzas Due to Undeclared Soy
Green Valley Foods is recalling approximately 4,062 pounds of frozen meat pizza products because they contain soy, a known allergen, that is not declared on the label.
Product
Green Valley Foods — Green Valley Foods Recalls Frozen Meat Pizza Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
3 states
SevereNHTSA·23V651000·2023-09-22
Hyundai Recalls Multiple Models Due to ABS Module Fire Risk
Hyundai is recalling over 1.6 million vehicles because a leaking ABS module may cause an engine compartment fire. Owners should park outside until the repair is complete.
Product
HYUNDAI — HYUNDAI ELANTRA, AZERA, SANTA FE, GENESIS COUPE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V649000·2023-09-22
2023 Kia Forte Right Front Control Arm Defect Recall
Kia is recalling 2023 Forte vehicles due to improper welds on the right front lower control arm, which may fail and cause loss of steering control. Affected owners should not drive the vehicle until repaired.
Product
KIA — KIA FORTE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V648000·2023-09-22
2024 East to West RV Recall: Detachable Rear Ladder Poses Injury Risk
Forest River is recalling certain 2024 East to West Blackthorn and Tandara fifth wheels. The rear ladder may detach due to improper anchoring, creating a potential injury risk.
Product
EAST TO WEST — EAST TO WEST BLACKTHORN, TANDARA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V650000·2023-09-22
2024 Hyundai Kona Seat Belt Retractor Malfunction Recall
Hyundai is recalling certain 2024 Kona vehicles because the rear seat belt retractors may not function properly. A defective seat belt could fail to restrain occupants in a crash, increasing injury risk.
Product
HYUNDAI — HYUNDAI KONA
Category
Vehicle
Distribution
Distributed nationwide
CriticalCPSC·23290·2023-09-21
HONEY JOY Infant Swings Recalled for Suffocation Hazard
HONEY JOY infant swings are recalled due to a suffocation hazard. The product violates federal safety standards because it has an incline angle greater than 10 degrees and was marketed for infant sleep, and infant fatalities have been reported in similar inclined sleepers.
Product
HONEY JOY Infant Swings
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·23V647000·2023-09-21
2023 Subaru Driveshaft Center Support Bolts May Loosen
Subaru is recalling certain 2023 Ascent, Legacy, Impreza, and Outback vehicles because center support bolts for the driveshaft may loosen, potentially causing the driveshaft to disconnect and increasing crash risk. Dealers will clean and replace the bolts at no charge.
Product
SUBARU — SUBARU OUTBACK, ASCENT, LEGACY, IMPREZA
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·23294·2023-09-21
Shimano 11-Speed Road Cranksets Recalled for Crash Hazard
Shimano is recalling about 680,000 bonded 11-speed road cranksets because the crank parts can separate and break, posing a crash hazard. Six injuries including bone fractures have been reported.
Product
11-Speed Bonded Hollowtech II Road Cranksets
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·23V645000·2023-09-21
Rolls-Royce Ghost Recall: Instrument Cluster Glass May Break in Crash
BMW is recalling 2021-2023 Rolls-Royce Ghost vehicles because the instrument cluster glass may break in a crash, increasing injury risk.
Product
ROLLS-ROYCE — ROLLS-ROYCE GHOST
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23292·2023-09-21
Rainbow Road Series Board Books Recall: Detachable Plastic Rings Choking Hazard
Make Believe Ideas recalls seven Rainbow Road Series board books because plastic binding rings can detach, posing a choking hazard to young children. About 260,000 units were sold nationwide from March 2022 through August 2023.
Product
Rainbow Road Series Board Books
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23793·2023-09-21
Novaform ComfortGrande and DreamAway Mattresses Recalled for Mold Contamination
FXI recalls about 48,000 Novaform mattresses from Costco due to mold contamination from water exposure during manufacturing. The mold poses a health risk to people with compromised immune systems or mold allergies. No injuries have been reported.
Product
Novaform ComfortGrande 14-inch and Novaform DreamAway 8-inch Mattresses
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23291·2023-09-21
DR Power Chipper Shredders Recalled Due to Laceration Hazard
DR Power Chipper Shredders are being recalled because metal pieces can come loose and be ejected, or the hopper can detach, both creating laceration hazards. The firm has received 79 reports of parts coming loose and 3 reports of hopper detachment, with a total of 3 reported injuries.
Product
DR Power Chipper Shredders
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23293·2023-09-21
H&M Men's Clasp Beaded Bracelets Recalled for High Lead Content
H&M is recalling about 12,290 men's clasp beaded bracelets because the clasp contains lead levels exceeding the federal ban. Lead is toxic if ingested by young children and can cause adverse health effects.
Product
Men's clasp beaded bracelets
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2509-2023·2023-09-20
Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode
Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.
Product
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery with
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2514-2023·2023-09-20
FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure
Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.
Product
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2510-2023·2023-09-20
Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode
Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.
Product
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1494-2023·2023-09-20
Zespri Organic Green Kiwi recalled for Listeria monocytogenes contamination
Zespri Organic Green Kiwi from New Zealand is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across 14 states.
Product
Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged in plastic clamshell, net wt. 1lb. UPC 818849020093. Distributed by The Oppenheimer Group, 180 Nickerson Street, Suite 211 Seattle WA. Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged
Category
Food
Distribution
14 states
SevereFDA (Food)·F-1495-2023·2023-09-20
Zespri Organic Green Kiwi Recalled Due to Listeria Contamination
Zespri Organic Green Kiwi from New Zealand has been recalled due to potential Listeria monocytogenes contamination. The recalled pallet was distributed across 14 U.S. states.
Product
Zespri Organic Green Kiwi, product of New Zealand, one pallet of bulk loose organic green kiwifruit was shipped to one consignee in Chicago, IL. The master carton has the barcode 067834 and the kiwi PLU label has the code GTIN 9400 9552.
Category
Food
Distribution
14 states
SevereFDA (Devices)·Z-2450-2023·2023-09-20
Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure
Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.
Product
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-1180-2023·2023-09-20
WEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil
WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.
Product
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2505-2023·2023-09-20
Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode
Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.
Product
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2511-2023·2023-09-20
Infinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure
Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.
Product
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2508-2023·2023-09-20
Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode
Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.
Product
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2507-2023·2023-09-20
Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure
Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.
Product
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2506-2023·2023-09-20
Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode
Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.
Product
Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1513-2023·2023-09-20
Natural Products Supplement Recalled Due to Mislabeling with Toxic Plant
Todorganic Inc. is recalling TODRGANIC Natural Products NUEZ DE LA INDIA (Lot 168, EXP 10/24) because the product contains Yellow Oleander instead of the labeled ingredient. Yellow Oleander is toxic if ingested.
Product
TODRGANIC Natural Products, NUEZ DE LA INDIA, Natural Products, 12 Seeds 12 Semillas
Category
Food
Distribution
0 states
SevereNHTSA·23V642000·2023-09-20
2023 Chevrolet Tahoe and Related Models Suspension Bolt Recall
General Motors is recalling certain 2023 Tahoe, Suburban, Escalade, Escalade ESV, Yukon, and Yukon XL vehicles due to improperly heat-treated rear suspension bolts that may break, risking wheel misalignment and crash.
Product
CADILLAC — CADILLAC, CHEVROLET, GMC ESCALADE ESV, SUBURBAN, TAHOE, YUKON
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1522-2023·2023-09-20
Texas Tamale Company Black Bean Tamales Recalled for Undeclared Milk
Texas Tamale Company is recalling Black Bean Tamales due to undeclared milk. The product poses a risk to consumers with milk allergies.
Product
Texas Tamale Black Bean Tamales 18 oz, (1 lb. 2 oz), 510 g
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2534-2023·2023-09-20
Procedural kits with ultrasonic transmission gel recalled for mislabeling
Advance Medical Designs, Inc. is recalling 26,900 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The affected products were distributed in the U.S., Canada, the UK, Panama, and the Netherlands.
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2564-2023·2023-09-20
Radiation monitoring dosimeter recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot radiation monitoring dosimeters due to a potential defect in the optical luminescence material that may result in inaccurate radiation dose readings.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2575-2023·2023-09-20
Landauer nanoDot Radiation Dosimeter Recalled for Accuracy Defect
Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.
Product
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2551-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may read outside the specified ±5.5% accuracy range due to a potential non-conformance in the Optical Stimulated Luminescence material.
Product
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2546-2023·2023-09-20
Medical Device: Radiation Dosimeter Units May Have Inaccurate Readings
Landauer nanoDot D2DXN radiation dosimeters may measure outside the specified +/-5.5% accuracy range due to a potential non-conformance in the optical stimulated luminescence material. Approximately 13,950 units were distributed worldwide.
Product
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2524-2023·2023-09-20
Medtronic Bone Graft Recalled Due to Incorrect Size Labeling
Medtronic Sofamor Danek USA Inc is recalling Magnifuse Bone Graft products due to incorrect size labeling on 55 pouches. Units with specific serial numbers were distributed in nine U.S. states.
Product
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1149-2023·2023-09-20
Prescription Drug Sucralfate Suspension Recalled for Out-of-Specification Potency
VistaPharm LLC is recalling Sucralfate Oral Suspension 1g/10mL due to out-of-specification assay results. The active ingredient concentration does not meet FDA specifications in approximately 14,400 affected bottles distributed nationwide.
Product
SUCRALFATE — SUCRALFATE (SUCRALFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2557-2023·2023-09-20
Radiation Dosimeter May Provide Inaccurate Dose Measurements
Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2582-2023·2023-09-20
ACUSON Redwood 2.0 Ultrasound Systems Display Incorrect Measurement Results
ACUSON Redwood 2.0 ultrasound systems may display underestimated measurement results when using an 18L6 transducer in Dual format, potentially leading to patient misdiagnosis. 796 units are affected worldwide.
Product
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1502-2023·2023-09-20
Sodium Nitrite Food Additive Recalled Due to Metal Fragment Contamination
Chemtrade Solutions is recalling food-grade Sodium Nitrite due to possible metal fragment contamination. The product may contain ferrous metal particles 1 mm or smaller.
Product
Sodium Nitrite, Granular Super Free-Flowing Food Grade, 50lb polyethylene and paper bags - 50 per pallet
Category
Food
Distribution
5 states
HighFDA (Food)·F-1503-2023·2023-09-20
Twin City Foods Frozen Corn Recalled Nationwide for Listeria Risk
Twin City Foods recalled frozen corn products due to potential Listeria monocytogenes contamination. Products distributed nationwide and internationally.
Product
Individually Quick Frozen (IQF) Corn distributed in BULK TOTES (1650lbs and 1750lbs) to consignees for further processing. Bulk tote labels have cooking instructions. Individually Quick Frozen (IQF) Super Sweet Corn, foodservice item, packaged in 32oz. plastic bag, 12 bags per
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2567-2023·2023-09-20
Landauer nanoDot radiation dosimeters may be outside accuracy specifications
Landauer is recalling nanoDot D2DNS radiation dosimeters that may be outside the specified +/-5.5% accuracy range. The issue involves a potential non-conformance in the optical measurement material.
Product
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1505-2023·2023-09-20
Twin City Foods Frozen Corn Recalled for Listeria Contamination Risk
Multiple frozen corn products distributed nationwide are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.
Product
Kernel Corn, BEST PRICE TOPVALU, net wt. per bag 300g. Label is in foreign language. UPC 4549414086232 Signature Select Golden Corn Super Sweet, Product of USA, net wt. per bag 12oz, 12 bags per case. UPC 21130090655 Food Lion Super Sweet Cut Yellow Corn, Product of USA, net wt
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1507-2023·2023-09-20
Southern Belle Crabmeat Stuffing Recalled for Plastic Contamination
Shaw's Southern Belle Frozen Foods recalled 600 pounds of Southern Belle Seafood Crabmeat Stuffing due to a plastic fragment found in the product. The affected lot is 042504 with a use-by date of 08/23/2023, distributed domestically.
Product
Southern Belle Seafood Crabmeat Stuffing, Packed: 2/25 lb. Bag, Net Weight: 50 lb. (22.68 kg), Use By: 08/23/2023
Category
Food
Distribution
0 states
HighFDA (Food)·F-1509-2023·2023-09-20
Trader Joe's Dark Chocolate Chunk and Almond Cookies Recalled for Rock Contamination
Trader Joe's Dark Chocolate Chunk and Almond Cookies are being recalled due to contamination with rocks. Approximately 110,088 units were distributed to stores in Pennsylvania, Florida, California, Texas, Illinois, Washington, and Arizona.
Product
Trader Joe's Dark Chocolate Chunk and Almond Cookies Net Wt. 13 oz.
Category
Food
Distribution
8 states
HighFDA (Food)·F-1512-2023·2023-09-20
US Foods Peanut Butter Toffee Bar recalled for possible plastic contamination
Killer Brownie Ltd is recalling US Foods Peanut Butter Toffee Bars (3.4oz) distributed in Illinois due to possible plastic foreign material. Consumers should not eat affected units.
Product
US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2552-2023·2023-09-20
Radiation dosimeter recalled for potential measurement accuracy deviations
Landauer recalled nanoDot D2DNS radiation dosimeters worldwide due to potential inaccuracy in Optical Stimulated Luminescence material. Some units may read outside the specified ±5.5% accuracy range.
Product
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1501-2023·2023-09-20
Cream Cheese Rangoon Recalled Due to Plastic Foreign Object
Pegasus Foods, Inc. is recalling Cream Cheese Rangoon due to the presence of plastic foreign objects in the product. Approximately 38,887 cases distributed in California are affected.
Product
Cream Cheese Rangoon NET WT: 5.00 LB. (2.26 KG) CT/CS: 100 PS (5 TRAYS X 20 PCS UPC: (01)10664383187016(15)112823(10)0601233A1W package in corrugated cardboard case.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2565-2023·2023-09-20
Landauer nanoDot radiation dosimeter units recalled due to accuracy failure
Landauer is recalling 973 radiation dosimeter units that may not accurately measure radiation exposure due to a potential defect in the light-emitting material used for dose measurement.
Product
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1511-2023·2023-09-20
Ritchie's Distribution Pizza Dough Recall Due to Undeclared Soy Allergen
Cassanos Inc is recalling Ritchie's Distribution Pizza Dough (lots 193, 194) distributed in Ohio due to undeclared soy flour. Consumers with soy allergies should not consume this product.
Product
Ritchie's Distribution Pizza Dough on Parchment: packaged as 16in (regular)
Category
Food
Distribution
1 state
HighFDA (Food)·F-1515-2023·2023-09-20
Knorr Soup Mix Recalled for Undeclared Egg Allergen
Conopco is recalling Knorr Fideos con Tomate Tomato Based Pasta Soup Mix because it contains undeclared egg. The product was distributed nationwide with best-by dates through July 6, 2024.
Product
Knorr Fideos con Tomate Tomato Based Pasta Soup Mix 3.5 oz UPC: 048001716162
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2538-2023·2023-09-20
Radiation monitoring dosimeter units recalled for potential accuracy defect
Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.
Product
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2588-2023·2023-09-20
FILMARRAY GI Panel Software Recalled for False Positive Cryptosporidium Results
BioFire Diagnostics is recalling FILMARRAY Gastrointestinal Panel software due to an increased risk of false positive Cryptosporidium test results. Approximately 61,069 devices were distributed in the US and internationally.
Product
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-2574-2023·2023-09-20
NanoDots radiation dosimeter recalled for potential measurement accuracy issues
Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.
Product
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1148-2023·2023-09-20
Pantoprazole Sodium for Injection Recalled Due to Sterility Concern
BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection nationwide due to lack of sterility assurance caused by powder discoloration and small cracks in some vials. No illnesses have been reported.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1506-2023·2023-09-20
Mixed Vegetables Recalled for Potential Listeria monocytogenes Contamination
Twin City Foods is recalling mixed vegetable products sold under TopValu, Food Lion, and Kroger brands due to potential Listeria monocytogenes contamination. Products were distributed in the US and internationally.
Product
Mixed Vegetables BEST PRICE TOPVALU, net per bag 500g. Label is in foreign language. 4549414484120 Food Lion Mixed Vegetables Carrots, Corn, Green Beans & Peas. Product of USA, net wt. per bag 16oz, 12 bags per case. Distributed by Food Lion, LLC Salisbury, NC. UPC 35826005090
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2560-2023·2023-09-20
Landauer nanoDot radiation dosimeter may report inaccurate dose readings
Landauer is recalling certain nanoDot radiation dosimeters worldwide due to a potential flaw in the optical stimulated luminescence material. Affected devices may provide inaccurate radiation dose readings.
Product
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2541-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for accuracy drift
Landauer is recalling nanoDot D2DNN radiation dosimeters because some units may have measurement accuracy outside their specified +/-5.5% range. Worldwide users should contact the manufacturer to verify device performance.
Product
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2553-2023·2023-09-20
Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift
Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.
Product
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2578-2023·2023-09-20
Medical Device Recall: ACL TOP Coagulation Analyzers for Sample Misidentification
Instrumentation Laboratory is recalling ACL TOP coagulation analyzers due to potential sample misidentification that could result in incorrect test results and alter patient management decisions.
Product
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2023·2023-09-20
Radiation Dosimeter Recall: nanoDot D2DNN Accuracy Outside Specifications
Landauer is recalling nanoDot D2DNN radiation dosimeters worldwide because some units may have measurement accuracy outside the specified +/-5.5% range. Approximately 36,805 units are affected.
Product
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2572-2023·2023-09-20
Landauer Radiation Dosimeter Recalled for Potential Measurement Inaccuracy
Landauer is recalling 1,880 units of the Constancy nanoDot D2DNN radiation dosimeter due to a potential non-conformance that may cause inaccurate radiation readings. The devices were distributed worldwide.
Product
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1510-2023·2023-09-20
Cassano's The Pizza King Premium Pizza Dough on Parchment Recalled for Undeclared Soy Allergen
Cassano's The Pizza King Premium Pizza Dough on Parchment is being recalled due to undeclared soy flour. Consumers with soy allergies should not consume the affected product.
Product
Cassano's The Pizza King Premium Pizza Dough on Parchment: packaged as 16in (regular)
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2571-2023·2023-09-20
Landauer nanoDot dosimeters recalled for potential accuracy deviation
Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.
Product
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1508-2023·2023-09-20
Trader Joe's Almond Windmill Cookies Recall: Rocks Found in Product
Fantasy Cookie Corporation is recalling Trader Joe's Almond Windmill Cookies because rocks were found in the product. Consumers should not eat affected cookies.
Product
Trader Joe's Almond Windmill Cookies Buttery, tender cookies topped with crunchy almonds. Net Wt. 15 oz.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-2554-2023·2023-09-20
Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy
Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.
Product
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2544-2023·2023-09-20
Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues
Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.
Product
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2570-2023·2023-09-20
Radiation monitoring dosimeters recalled for potential measurement inaccuracy
Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters worldwide due to a potential material defect that may cause readings to fall outside the specified ±5.5% accuracy range.
Product
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1516-2023·2023-09-20
Knorr Alphabet Pasta Soup Recalled for Undeclared Egg Allergen
Knorr Letras con Tomate soup mix is being recalled because it contains undeclared egg. Consumers with egg allergies should not consume this product.
Product
Knorr Letras con Tomate Tomato Based Alphabet Pasta Soup Mix 3.5 oz UPC: 048001716186
Category
Food
Distribution
Distributed nationwide
HighNHTSA·23V643000·2023-09-20
Tiffin motorhomes recalled for cooktop electrical shock hazard
Tiffin is recalling certain 2016-2024 Allegro Bus and 2017-2024 Zephyr motorhomes because the 240-volt cooktop may not be grounded, creating an electrical shock hazard. Tiffin will install a ground for the junction box at no charge.
Product
TIFFIN — TIFFIN ALLEGRO BUS, ZEPHYR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2537-2023·2023-09-20
Ultrasound gel procedural kits recalled for mislabeled use instructions
Advance Medical Designs is recalling 1880 ultrasound gel procedural kits due to mislabeling that indicates inappropriate use. The affected kits were distributed in the US, Canada, UK, Panama, and the Netherlands.
Product
procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2548-2023·2023-09-20
Landauer nanoDot D2DXS Dosimeter Recall for Measurement Accuracy
Landauer is recalling nanoDot D2DXS radiation dosimeters that may not accurately measure radiation exposure. Some units may fall outside the specified ±5.5% accuracy range due to a potential defect in the optical stimulated luminescence material.
Product
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2550-2023·2023-09-20
Landauer nanoDot radiation dosimeter recalled for potential measurement inaccuracy
Landauer is recalling nanoDot D2DNS radiation dosimeters worldwide because some units may measure radiation exposure inaccurately, potentially outside the specified +/-5.5% accuracy range. The issue involves the optical stimulated luminescence material used to detect radiation.
Product
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1514-2023·2023-09-20
Knorr Pasta Soup Mix recalled for undeclared egg allergen
Conopco (Unilever) recalled Knorr Estrellitas con Tomate soup mix nationwide due to undeclared egg allergen. No illnesses have been reported.
Product
Knorr Estrellitas con Tomate Tomato Based Star Pasta Soup Mix 3.5 oz UPC: 048001716193
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1504-2023·2023-09-20
Frozen Corn Recalled Due to Listeria monocytogenes Contamination
Twin City Foods frozen corn in bulk cases is recalled nationwide due to potential Listeria monocytogenes contamination. Products were distributed to food processors in the United States, Costa Rica, China, and Japan.
Product
Individually Quick Frozen (IQF) Corn, distributed in bulk cases (1kg, 10kg, 12kg, 15kg, 25kg) to consignees for further processing. Cases are read in parts: Product of U.S.A. Packed By Twin City Foods, Inc. Stanwood, Washington. Super Sweet Grade A Cut Corn Blanched Vegetables,
Category
Food
Distribution
Distributed nationwide
HighNHTSA·23V644000·2023-09-20
BMW Recalls 2023 740i, 760i, and i7 Models for Wiper Failure
BMW is recalling 2023 740i, 760i, and i7 vehicles because windshield wipers may fail in certain weather, reducing visibility and increasing crash risk.
Product
BMW — BMW 760I, I7, 740I
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2547-2023·2023-09-20
Radiation Monitoring Dosimeter Potential Accuracy Error: Worldwide Landauer nanoDot Recall
Landauer is recalling nanoDot D2DXS radiation monitoring dosimeters worldwide due to a potential non-conformance that could cause some units to measure radiation exposure outside the specified +/-5.5% accuracy range.
Product
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighNHTSA·23V674000·2023-09-20
GM Recalls 2014 Buick Verano and Chevrolet Cruze for Air Bag Defect
General Motors is recalling 2014 Buick Verano and Chevrolet Cruze vehicles because side roof-rail air bag inflators may rupture, potentially causing injury from metal fragments.
Product
CHEVROLET — CHEVROLET, BUICK CRUZE, VERANO
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V646000·2023-09-20
Wabash National Dry Van Trailers Recalled for Rear Impact Guard Defect
Wabash National is recalling certain 2009-2024 dry van trailers because the rear impact guard is positioned too far forward, potentially reducing crash protection. Dealers will add an extension to the guard free of charge.
Product
WABASH NATIONAL — WABASH NATIONAL VAN
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2539-2023·2023-09-20
Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance
Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.
Product
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2587-2023·2023-09-20
Philips X-Ray Systems Recalled for Foot Switch Malfunction Risk
Philips Allura and Azurion x-ray imaging systems are being recalled due to a damaged foot switch component that may prevent or intermittently disable x-ray radiation initiation. Approximately 19,115 systems are affected worldwide.
Product
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2577-2023·2023-09-20
BeamAdjust software generates incorrect calibration files for radiation detectors
BeamAdjust software Version 2.3.3 generates incorrect calibration files when using TIFF or DICOM image reference data, affecting radiation measurement accuracy in OCTAVIUS Detector systems.
Product
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector
Category
Medical Device
Distribution
Distributed nationwide

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