Safety Recalls

15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 9,701–9,750 of 15,364

• Medical Device Recall · October 14, 2024

  Defibtech, LLC

  Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden

  Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

  Class II

• Medical Device Recall · October 14, 2024

  Cook Incorporated

  Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

  Devices from the affected device lots have labels that state the incorrect expiration dates.

  Class II

• Medical Device Recall · October 14, 2024

  Defibtech, LLC

  Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)

  Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

  Class II

• Food Recall · October 12, 2024

  DANONE US LLC

  Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated.

  The International Delight Zero Sugar Peppermint Mocha is recalled because it was mis-labeled as zero sugar but it contains sugar.

  Class II

• Vehicle Recall · October 12, 2024

  PACCAR Incorporated

  2023 KENWORTH T280, 2023 KENWORTH T680, 2023 PETERBILT 579, 2024 KENWORTH T680, 2024 KENWORTH T880, 2024 PETERBILT 548, 2024 PETERBILT 579, 2024 PETERBILT 567, 2024 PETERBILT 389, 2025 KENWORTH T380,

  Safety systems that depend on the ECU (Automatic Traction Control, ABS, Electronic Stability Control, Active Cruise Control, and Collison Mitigation System) may not function properly or at all, increasing the risk of a crash.

  Unclassified

• Vehicle Recall · October 12, 2024

  Grand Design RV, LLC

  2023 GRAND DESIGN MOMENTUM, 2024 GRAND DESIGN MOMENTUM, 2025 GRAND DESIGN MOMENTUM

  The tread may detach from the step, increasing the risk of a trip and fall injury.

  Unclassified

• Vehicle Recall · October 12, 2024

  Chrysler (FCA US, LLC)

  2023 JEEP RENEGADE

  The incorrect reverse lights may have reduced visibility, and not alert pedestrians and other drivers that the vehicle is backing up, increasing the risk of a crash.

  Unclassified

• Food Recall · October 11, 2024

  CON YEAGER SPICE CO.

  Con Yeager Spice Company, Trail Bologna Meat Processing Kit, 17.88 Ounce pouches, UPC code 797442404137

  Undeclared Allergen - Wheat and Soy

  Class I

• Medical Device Recall · October 11, 2024

  Baxter Healthcare Corporation

  Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

  There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  Class II

• Food Recall · October 11, 2024

  The Kroger Co

  Home Chef Chicken Street Taco, Net Wt. 9.93 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430435, all lot codes

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Medical Device Recall · October 11, 2024

  Baxter Healthcare Corporation

  Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

  There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  Class II

• Food Recall · October 11, 2024

  CONTINENTAL DAIRY FACILITIES SOUTHWEST LLC

  Kirkland Signature Salted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38488.

  Butter lists cream, but may be missing the Contains Milk statement.

  Class II

• Medical Device Recall · October 11, 2024

  Karl Storz Endoscopy

  4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 12

  Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

  Class II

• Medical Device Recall · October 11, 2024

  Ortho-Clinical Diagnostics, Inc.

  VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

  May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

  Class II

• Food Recall · October 11, 2024

  Dakota Tom's, Inc

  The Gambler, Dakota Toms brand, Net Wt 7.8 oz, individual pre-packaged components in MEP packaging, UPC 737296601788

  Potential Listeria monocytogenes contamination

  Class I

• Drug Recall · October 11, 2024

  Padagis US LLC

  Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

  Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

  Class III

• Medical Device Recall · October 11, 2024

  Baxter Healthcare Corporation

  Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring

  There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  Class II

• Food Recall · October 11, 2024

  Dakota Tom's, Inc

  Pepperjack Cheese Burger, Dakota Toms brand, Net Wt 5.7 oz, individual pre-packaged components in MEP packaging, UPC 737296806008

  Potential Listeria monocytogenes contamination

  Class I

• Food Recall · October 11, 2024

  Sprouts Farmers Market

  Sprouts Chicken Street Taco, 6 taco, perishable item kept under refrigeration, packaged in a plastic tray with plastic lid, Net wt of 1.5lbs, UPC 205916813991. Sell by dates of 9/2/2024 to 11/7/2024.

  Sprout Chicken Street Taco 6 Tacos contains cooked chicken that is associated with a recall due to Listeria monocytogenes contamination.

  Class II

• Medical Device Recall · October 11, 2024

  Baxter Healthcare Corporation

  Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

  There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  Class II

• Medical Device Recall · October 11, 2024

  Baxter Healthcare Corporation

  Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

  There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  Class II

• Food Recall · October 11, 2024

  HH FRESH TRADING CORP

  ENOKI MUSHROOM; 200g/package (25 packages/case); vacuum packed; refrigerated "***ENOKI MUSHROOM***Net WT***200g(1.05oz)***To keep sealed & cold Product of Taiwan Distributed by: HH Fresh Trading Los

  Potential contamination of Listeria monocytogenes

  Class I

• Food Recall · October 11, 2024

  Dakota Tom's, Inc

  Bacon Cheeseburger , Dakota Toms brand, Net Wt 5.7 oz, individual pre-packaged components in MEP packaging, UPC 737296803007

  Potential Listeria monocytogenes contamination

  Class I

• Food Recall · October 11, 2024

  The Kroger Co

  Home Chef Asian Style Chicken Stir Fry, Net Wt. 13 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430852, all lot codes

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Food Recall · October 11, 2024

  CONTINENTAL DAIRY FACILITIES SOUTHWEST LLC

  Kirkland Signature Unsalted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38496.

  Butter lists cream, but may be missing the Contains Milk statement.

  Class II

• Medical Device Recall · October 11, 2024

  Baxter Healthcare Corporation

  Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

  There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  Class II

• Drug Recall · October 10, 2024

  ACCORD HEALTHCARE, INC.

  Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured b

  CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

  Class II

• Medical Device Recall · October 10, 2024

  Philips Medical Systems Technologies Ltd.

  Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and

  A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

  Class II

• Medical Device Recall · October 10, 2024

  Boston Scientific Corporation

  Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100

  Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

  Class I

• Consumer Product Recall · October 10, 2024

  Fisher-Price of East Aurora, New York

  All Models of Fisher-Price Snuga Swings

  The swing should never be used for sleep and bedding materials should never be added to it. If the product is used for sleep or bedding material is added, the headrest and body support insert on the seat pad can increase the risk of suffocation.

  Unclassified

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 404852, UPC 71117 12507, Don Pancho Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Case GTIN 10071117125075, Case UPC 7111712507, D

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Food Recall · October 10, 2024

  Albertsons Companies LLC

  (1) READY MEALS GREEN CHILI CHICKEN ENCHILADAS SS COLD (UPC 21291600000) (2) GREEN CHICKEN ENCHILADAS 6 CT SS COLD (UPC 27163500000)

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Medical Device Recall · October 10, 2024

  Boston Scientific Corporation

  Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

  Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

  Class I

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 407121, UPC 13454 38496, Bistro 28 Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Distributed by Fresh Creative Foods, Vista, CA. Cas

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 404700, UPC 13454 38075, Premium Street Taco Kit With Trays, 2/4.9875 lbs. Distributed by Fresh Creative Foods Vista, CA.

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 404711, UPC 13454 38082, Don Pancho Kit OP Street Taco Chicken NO Trays, 4.985 lb. Case GTIN 10013454380823, Case UPC Code 1345438082, Don Pancho Kit OP Street Taco Chicken NO Trays. 2/4.985 lb

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Medical Device Recall · October 10, 2024

  Boston Scientific Corporation

  Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

  Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

  Class I

• Food Recall · October 10, 2024

  Whitsons Food Service (Bronx), LLC

  New Horizen Gourmet BBQ Pulled Chicken Sandwich on Everything Bialy; KEEP FROZEN; COOK & SERVE; Cooking Instructions: Conventional oven (Preheat oven to 350oF). Thaw product overnight. Cook meal for 2

  Product may be contaminated with Listeria monocytogenes.

  Class II

• Food Recall · October 10, 2024

  Enoki King Mushroom Farm Inc.

  (Principal Display) ENOKI MUSHROOM Champignons d'enoki Net Wt: 150g (5.3oz) in a clear plastic packaged. (Back Display) UPC 860011505600 Keep Refrigerated Garder Au Froid Distributed by: Global Fresh

  The product was found to have Listeria monocytogenes

  Class I

• Medical Device Recall · October 10, 2024

  Boston Scientific Corporation

  Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

  Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

  Class I

• Drug Recall · October 10, 2024

  Breckenridge Pharmaceutical, Inc

  Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.

  CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

  Class II

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 404710, UPC 13454 38080, Chicken Street Taco Kit with Trays, 4.985 lb. Item 13454 38080 Chicken Street Taco Kit with Trays, 2/4.985 lb. bags per case. Distributed by Fresh Creative Foods, Vist

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 401311, UPC 13454 35855, Caesar Salad Kit 2/6 lbs. Distributed by Fresh Creative Foods Vista, CA.

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class I

• Medical Device Recall · October 10, 2024

  Boston Scientific Corporation

  Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

  Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

  Class I

• Vehicle Recall · October 10, 2024

  General Motors, LLC

  2024 GMC SIERRA EV

  Front turn signals that are difficult to see may not clearly indicate the driver's intentions to other road users, increasing the risk of a crash.

  Unclassified

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 407119, UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. Ready in 5 MIN. Net wt. 25 oz (1 LB 9 OZ) 788g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384944

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Consumer Product Recall · October 10, 2024

  Shenzhen Jingdu Technology Co. Ltd., of China

  Gimars Playpen with Mat

  The recalled playpens violate the federal safety regulations for play yards. The included basketball hoop accessory can be a head entrapment hazard and children can become entrapped beneath the mattress, posing a suffocation hazard.

  Unclassified

• Vehicle Recall · October 10, 2024

  Kia America, Inc.

  2024 KIA EV9, 2025 KIA EV9

  An instrument panel screen that fails to display critical safety information, such as the speedometer or warning lights, can increase the risk of a crash.

  Unclassified

• Food Recall · October 10, 2024

  Reser's Fine Foods, Inc.

  Item 406581, UPC 40134 30435, Home Chef Kit Street Taco Chicken With Tray, 2/4.985 LB. Distributed by Fresh Creative Foods, Vista, CA or by Reser's Fine Foods Inc. Beaverton, OR. Item 406581, UPC 401

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II

• Food Recall · October 10, 2024

  Albertsons Companies LLC

  (1) READY MEALS CHICKEN STREET TACOS SS COLD (UPC 27131600000) (2) READY MEALS ASADA STREET TACO MEAL SS COLD (UPC 29939100000) (3) READY MEALS CHICKEN STREET TACO MEAL SM SS COLD (UPC 27179600000)

  Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes

  Class II