Safety Recalls

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15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 8,551–8,600 of 15,362

Food Recall · January 7, 2025
FGF, LLC
item 8201920 APPLE CRISP CK DONUT PFD 78x3OZ, NET WT 13.16 LB
potential for contamination with listeria monocytogenes
Class II
Food Recall · January 7, 2025
FGF, LLC
item 8201883 UNFLD BISMARK DONUT PFD 57x2.75OZ, NET WT 8.82 LB
potential for contamination with listeria monocytogenes
Class II
Food Recall · January 7, 2025
FGF, LLC
item 8201904 JUST BAKED CHOCOLATE CAKE RINGS ARTIFICIALLY FLAVORED 144x2.5OZ, NET WT 22.5 LB
potential for contamination with listeria monocytogenes
Class II
Medical Device Recall · January 6, 2025
Sysmex America, Inc.
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cyto
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Class II
Medical Device Recall · January 6, 2025
Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Class II
Food Recall · January 6, 2025
The Mochi Ice Cream Company
My Mochi Sorbet Peach Mango Sorbet; Keep Frozen; 6 pieces per container; 6-1.25 OZ (35g) PIECES NET WT 7.5 OZ (210g)*** Nutritional Panel: 6 servings per container; JOYFULLY CHILL!; Made in a nut-free
Frozen Peach Mango Sorbet contains undeclared allergen (egg)
Class I
Food Recall · January 6, 2025
United Natural Trading Inc. dba Woodstock Farms
Wegmans, Organic Almonds Dry Roasted Salted, 12oz clear bag, 12 bags per case.
Product mislabeled. The back label states Organic Cashews. The front product label states Wegmans Organic unsalted dry roasted almonds. The front label is correct label for this product.
Class II
Food Recall · January 6, 2025
D.F.S. International, Ltd.
Daniele brand First Cold Press EXTRA VIRGIN OLIVE OIL; NET 101.4 FL. OZ. (3 QT. 5.4 FL. OZ.) 3L; IMPORTED; Distributed by: dfs international ltd Springfield, ma 01104; INGREDIENTS: EXTRA VIRGIN OLIVE
Product is likely Canola Oil, not Extra Virgin Olive Oil
Class III
Medical Device Recall · January 6, 2025
Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Class II
Vehicle Recall · January 5, 2025
Brinkley RV
2024 BRINKLEY RV MODEL Z, 2024 BRINKLEY RV MODEL G, 2025 BRINKLEY RV MODEL Z
Steps that detach while in use increase the risk of injury.
Unclassified
Medical Device Recall · January 5, 2025
Biosense Webster, Inc.
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used
Due to an observed trend of neurovascular events
Class I
Vehicle Recall · January 5, 2025
Keystone RV Company
2025 KEYSTONE KODIAK
The operator may be unable to handle the patio's weight, increasing the risk of injury.
Unclassified
Vehicle Recall · January 4, 2025
BMW of North America, LLC
2025 BMW 430I, 2025 BMW 430I XDRIVE, 2025 BMW X3
A loose starter-generator connection can result in an engine stall, increasing the risk of a crash. In addition, the wiring may overheat, increasing the risk of a fire.
Unclassified
Food Recall · January 3, 2025
Middle East/ Soli's Baking Company, Inc. dba Middle East Baking Co.
CAIRO BAKERY PITA POCKET BREAD TRADITIONAL RECIPE EXTRA LARGE 6 COUNT, NET WT. 16 OZ. (1 lb.) (454g)
Undeclared milk
Class I
Food Recall · January 3, 2025
Dierbergs Markets, Inc.
Dierbergs Kitchen 16 oz Mac & Cheese packaged in a black plastic container with a clear plastic lid with a white label, The label states "Dierbergs Kitchen Homestyle Mashed Potatoes UPC 231220-006538"
Undeclared allergens (wheat) on label, incorrect label was placed on product
Class II
Medical Device Recall · January 3, 2025
LivaNova USA, Inc.
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Sti
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Class II
Medical Device Recall · January 3, 2025
LivaNova USA, Inc.
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vag
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Class II
Medical Device Recall · January 3, 2025
XTANT Medical Holdings, Inc
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Class II
Medical Device Recall · January 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Class II
Medical Device Recall · January 2, 2025
Scientia Vascular, Inc.
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute is
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Class II
Medical Device Recall · January 2, 2025
Beckman Coulter Inc.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Class II
Consumer Product Recall · January 2, 2025
DingLinWangLuoKeJiGuang ZhouYouXianGongSi, dba DLWL-US, of China
Euqee Wintergreen Essential Oils
The essential oil contains methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging for the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
Unclassified
Medical Device Recall · January 2, 2025
US Endodontics, LLC
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP1
Due to devices being irradiated above the established specification which my result in package integrity issues.
Class II
Medical Device Recall · January 2, 2025
SIEMENS MEDICAL SOLUTIONS USA, INC
ARTIS One Angiographic X-Ray System
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Class II
Medical Device Recall · January 2, 2025
Belmont Instrument LLC
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Class II
Consumer Product Recall · January 2, 2025
Kawasaki Motors Manufacturing Corp. U.S.A. (engine manufacturer), of Maryville, Missouri
John Deere ZTrak™ Zero Turn Mowers with Kawasaki Engines
The voltage regulator in the mower's engine can fail during use or while the product is being stored, causing the engine to overheat, posing fire and burn hazards.
Unclassified
Consumer Product Recall · January 2, 2025
Wuhannuoyunxindianzikejiyouxiangongsi, (dba LordRoads), of China
Yaomiao Children's Jewelry Sets
The recalled jewelry sets contain levels of lead that exceed the federal lead content ban and levels of cadmium that are prohibited in children's products by the Federal Hazardous Substances Act. Lead and cadmium are toxic if ingested by young children and can cause adverse health effects.
Unclassified
Medical Device Recall · December 31, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Class I
Medical Device Recall · December 31, 2024
Exactech, Inc.
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II
Medical Device Recall · December 31, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Class I
Medical Device Recall · December 31, 2024
Exactech, Inc.
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II
Food Recall · December 31, 2024
The Granola Bar
The Granola Bar brand The OG Bar; 4 oz; Ingredients: Oats, brown sugar, honey, almonds, butter, olive oil, cashews, coconut flakes, chia seeds, vanilla extract, kosher salt; Contains: Tree nuts. Baked
Product contains undeclared milk and soy.
Class II
Medical Device Recall · December 31, 2024
Exactech, Inc.
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II
Food Recall · December 30, 2024
V Chocolates, Inc
Assorted Chocolate Caramels with kosher sea salt, Net Weight 1.25lb
Small pieces of plastic broken tray in the product.
Class II
Drug Recall · December 30, 2024
Granules Pharmaceuticals Inc.
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceutica
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II
Drug Recall · December 30, 2024
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II
Drug Recall · December 30, 2024
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II
Drug Recall · December 30, 2024
Rising Pharma Holding, Inc.
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II
Medical Device Recall · December 28, 2024
Neilmed Pharmaceuticals Inc
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a sa
Due to nasal spray stability failure for bioburden.
Class II
Drug Recall · December 27, 2024
Eugia US LLC
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class II
Food Recall · December 27, 2024
Braga Fresh Foods LLC
Marketside, BROCCOLI FLORETS, 12oz, BEST IF USED BY DEC 10 2024, PRODUCT OF USA, MEXICO
Potential contamination with Listeria monocytogenes.
Class I
Food Recall · December 27, 2024
Mi Ranchito Foods, Incorporated
Green Chile Bean Burrito, 15 days refrigerated at 33 45 degrees Fahrenheit. 120 days frozen at or below 32 degrees Fahrenheit. Packaged in cellophane wrapper. Net wt. 10 ounces, UPC #21856 11136.
Milk not listed in the ingredients or included in parentheses after American Cheese.
Class II
Medical Device Recall · December 26, 2024
ROi CPS LLC
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Class I
Consumer Product Recall · December 26, 2024
Playdale Playgrounds LTD, of United Kingdom
Inclusive Orbit merry-go-rounds
The space between the rotating platform and the stationary outer rim can leave a gap that narrows too much, posing a crushing hazard to children.
Unclassified
Consumer Product Recall · December 26, 2024
Black Diamond Equipment Ltd., of Salt Lake City, Utah
PIEPS Pro IPS Avalanche Transceivers
The battery compartment within the avalanche transceiver could not have enough contact force to supply power. In some cases, the transceiver will fail to power on or cease operating during use. It would make it impossible to locate a victim in an avalanche emergency situation, which could result in serious injury or death.
Unclassified
Consumer Product Recall · December 26, 2024
Shenzhen Leader-Union Technology Co. LTD, of China
GIKPAL 12-Drawer Dressers
The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate performance and warning label requirements of the STURDY Act.
Unclassified
Consumer Product Recall · December 26, 2024
Precor Incorporated, of Woodinville, Washington
Precor Resolute Cable Multi-Station Exercise Equipment
The pop-pin can fail to fully engage in the exercise equipment's vertical rail and cause the pulley carriage to drop unexpectedly during use, posing an impact injury hazard to users.
Unclassified
Medical Device Recall · December 23, 2024
Hollister Incorporated
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Class II
Medical Device Recall · December 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Class II
Medical Device Recall · December 23, 2024
Hollister Incorporated
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Class II