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 9,051–9,100 of 15,362

Food Recall · November 27, 2024
Gracie's Kitchens Inc.
a.) King Kullen brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic container b.) Wild By Nature brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic c.) Gracie's Kitchen brand Fiesta Bowl; UPC: 85316-1
Product may be contaminated with Listeria monocytogenes.
Class II
Food Recall · November 27, 2024
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Broccoli & Cauliflower Florets; UPC: 85316-1009; 12 oz foam tray
Product may be contaminated with Listeria monocytogenes.
Class II
Food Recall · November 27, 2024
Gracie's Kitchens Inc.
a.) King Kullen brand Fiesta Watermelon Bowl; UPC: 85316-10200; 60 oz plastic container b.) Gracie's Kitchen brand Fiesta Watermelon Bowl; UPC: 85316-10202; 60 oz plastic container
Product may be contaminated with Listeria monocytogenes.
Class II
Food Recall · November 27, 2024
Delta Fresh LLC.
Product is a whole, fresh cucumber with no individual packaging, labeling, PLU, or other identifying information. Cucumber weight and size varies. Type of master packaging: 1.PACKAGED IN BULK IN 1 1
Potential Salmonella contamination of fresh cucumbers. Associated with an outbreak.
Class I
Food Recall · November 27, 2024
Gracie's Kitchens Inc.
a.) King Kullen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container b.) Gracie's Kitchen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container
Product may be contaminated with Listeria monocytogenes.
Class II
Food Recall · November 27, 2024
Bazzini LLC
NuGo Dark Pretzel/Chocolate Chip Multipack 18 ct., 50g bar, 18 bars/tray, 9 trays/case. 40case/pallet
The product is being recalled because of undeclared milk .
Class I
Food Recall · November 27, 2024
Gracie's Kitchens Inc.
a.) Gracie's Kitchen brand Diced Carrots; UPC: 85316-10019; 10 oz plastic container
Product may be contaminated with Listeria monocytogenes.
Class II
Medical Device Recall · November 27, 2024
3B Medical, Inc.
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrat
The devices were inadvertently shipped after their expiration date.
Class II
Food Recall · November 27, 2024
Gracie's Kitchens Inc.
a.) King Kullen brand Mango; UPC: 85316-10377; 12 oz plastic container b.) King Kullen brand Mango Spears; UPC: 85316-10387; 16 oz plastic container c.) Wild by Nature brand Mango; UPC: 85316-10377; 1
Product may be contaminated with Listeria monocytogenes.
Class II
Medical Device Recall · November 27, 2024
IsoTis OrthoBiologics, Inc.
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Class II
Medical Device Recall · November 27, 2024
Trokamed GmbH
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Class I
Food Recall · November 26, 2024
SunFed Produce, Inc.
Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 BU CAS Select Slicer Cuc
Cucumbers potentially contaminated with Salmonella.
Class I
Medical Device Recall · November 26, 2024
3M Unitek Corporation
3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in th
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Class II
Drug Recall · November 26, 2024
Curium US, LLC
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tet
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II
Medical Device Recall · November 26, 2024
Applied Medical Technology Inc
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Class II
Medical Device Recall · November 26, 2024
O&M HALYARD, INC.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class II
Medical Device Recall · November 26, 2024
Beckman Coulter, Inc.
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.
Class II
Food Recall · November 26, 2024
Handsome Brook Farms, LLC
Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WHOLESALE CORPORATION 730 LAKE DRIVE, ISSAQUAH, WA 98
Eggs from a positive Salmonella environment were shipped into distribution to retail facilities.
Class I
Medical Device Recall · November 25, 2024
GE Medical Systems, LLC
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8)
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Softw
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spectranetics Corporation
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Angiodynamics, Inc.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Class II
Drug Recall · November 25, 2024
Macleods Pharmaceuticals Ltd
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured
Failed Impurities/Degradation Specifications
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Ltd.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Food Recall · November 25, 2024
SE Tampa Inc dba Tampa Food
Crab Cheese Rangoon, NET WT: 8 LB, 120 pieces of 30g / 3 Trays per master cardboard boxes, Keep Frozen, packaged in corrugated cardboard box.
Undeclared allergens: Milk, Soy, Crustacea Shellfish, Fish
Class I
Medical Device Recall · November 25, 2024
GE Medical Systems, LLC
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class II
Medical Device Recall · November 25, 2024
GE Medical Systems, LLC
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Ltd.
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 22, 2024
Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II