Safety Recalls

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15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 12,851–12,900 of 15,379

Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
GE Healthcare Finland Oy
CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001, 2) 2095801-001-01018416, 3) 2095801-001-01023150, 4) 2095801-001-01023151, 5) 2095801-001-01023152, 6) 2095801-001-01
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Wishbone Medical, Inc.
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use C
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Co
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use C
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Consumer Product Recall · April 4, 2024
Koala Tree Enterprises, DBA Lovey & Grink, of Los Angeles, California
Children's Two-Piece Pajamas and Lounge Dresses
The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
Unclassified
Medical Device Recall · April 4, 2024
Philips Medical Systems Nederland B.V.
Philips IntelliSpace Cardiovascular software, Model 830089.
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Class II
Consumer Product Recall · April 4, 2024
Shuangma Plastic Manufacturing Inc., of China
Mainstays Electric Mini Choppers
The chopper's blade can operate unexpectedly during assembly or when not enclosed in the container, posing a laceration hazard to consumers.
Unclassified
Medical Device Recall · April 4, 2024
Macherey Nagel Gmbh & Co. Kg
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative. The following HSI item number and lot number were affected: Urispec¿ 11-Way, #102-2285, LOT 65402.
Class II
Medical Device Recall · April 4, 2024
Stryker Leibinger GmbH & Co. KG
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons hig
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
Class II
Consumer Product Recall · April 4, 2024
Zazaba International Inc., of Dania Beach, Florida
Grão de Gente Baby Nests
The recalled baby nests violate the safety requirements of CPSC's Safety Standard for Infant Sleep Products, posing a suffocation risk and fall and entrapment hazards to infants. The failures include not having a stand and not meeting the requirements for side height, sleeping pad thickness, and fabric-sided openings. The product's sides are shorter than the minimum side height limit; the sleeping pad's thickness exceeds the maximum limit; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped.
Unclassified
Consumer Product Recall · April 4, 2024
Excalibur Crossbow US LLC, of Canada
C2 Crank Cocking Aid for Crossbows
The C2 Crank's cocking hooks can break during use, causing flying plastic hook projectiles, posing impact injury and laceration hazards to the user and bystanders.
Unclassified
Consumer Product Recall · April 4, 2024
Spectrum Brands Inc., of Middleton, Wis., owns subsidiary Empower Brands LLC
BLACK+DECKER Model HGS011 Easy Garment Steamers
The steamers can expel, spray, or leak hot water during use, posing a burn hazard to consumers.
Unclassified
Consumer Product Recall · April 4, 2024
Essential Medical Supply Inc., of Orlando, Florida
Endurance® Hand Bed Rails
When attached to an adult's bed, users can become entrapped within the bed rail or between the rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.
Unclassified
Consumer Product Recall · April 4, 2024
Thule, of Seymour, Connecticut
Thule RideAlong rear-mounted Child Bike Seats
The harness padding of Thule RideAlong bike seats can contain flame-retardant DecaBDE in excess of regulatory limits, posing a chemical hazard. DecaBDE can be toxic if it is ingested or comes into contact with skin or eyes.
Unclassified
Consumer Product Recall · April 4, 2024
Zazaba International Inc., of Dania Beach, Florida
Grão de Gente Crib Bumper Bedding Sets
Infants can suffocate if they roll or move on the crib bumper in a position that obstructs breathing. Padded crib bumpers are banned under the Safe Sleep for Babies Act of 2021.
Unclassified
Vehicle Recall · April 3, 2024
Nova Bus (US) Inc.
2023 NOVA BUS LFS
An inoperative battery disconnect switch increases the risk of electrical shock and injury during maintenance and repairs.
Unclassified
Medical Device Recall · April 3, 2024
Olympus Corporation of the Americas
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal
Potential for distal end of the sheath to break off during a procedure.
Class II
Food Recall · April 3, 2024
Reposteria Artesanal Laura
Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz,
Failure to declare FD&C Red #40, Red #3,Yellow #5, Yellow #6, Blue #1 and Blue #2
Class II
Food Recall · April 3, 2024
World Green Nutrition Inc.
ELV Control Herbal Supplement; 90 Capsules
FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans.
Class I
Medical Device Recall · April 3, 2024
Stryker Neurovascular
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophil
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
Class II
Medical Device Recall · April 2, 2024
Andover Healthcare Inc.
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
A packaging seal gap could impact the sterility of the product.
Class II
Medical Device Recall · April 2, 2024
Agilent Technologies
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Descriptio
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Class II
Drug Recall · April 2, 2024
X-Gen Pharmaceuticals Inc.
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III
Drug Recall · April 2, 2024
X-Gen Pharmaceuticals Inc.
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III
Medical Device Recall · April 2, 2024
Fisher & Paykel Healthcare, Ltd.
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Class II
Food Recall · April 2, 2024
Taylor Farms Southwest, Inc
Family Size Garden Salad 17oz packaged in Flexible plastic combo 32 oz clamshell.
On 03/30, TFSW ALBSWY CHICKEN CAESAR SALAD 10OZ (Egg, F-Anchovy, Milk, Soy, Wheat) was mislabeled with undeclared allergens as ALBSWY GARDEN SALAD 17OZ (Milk, Wheat)
Class II
Medical Device Recall · April 1, 2024
Cook Medical Incorporated
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Devices may contain elevated levels of bacterial endotoxin.
Class II
Medical Device Recall · April 1, 2024
Cook Medical Incorporated
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Devices may contain elevated levels of bacterial endotoxin.
Class II
Medical Device Recall · April 1, 2024
Karl Storz Endoscopy
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Class II
Medical Device Recall · April 1, 2024
Philips Respironics, Inc.
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
Class I