Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,901–13,950 of 15,379
- Class II
Medical Device Recall · January 29, 2024
Olympus Corporation of the Americas
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Class II
Medical Device Recall · January 29, 2024
Canon Medical System, USA, INC.
MRI system: Vantage Elan, Model: MRT-2020For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Class II
Medical Device Recall · January 26, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BDue to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
- Class II
Medical Device Recall · January 26, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
- Class II
Medical Device Recall · January 26, 2024
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350Due to reports of intraoperative graft bolt implantation breakages.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 25, 2024
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cementDue to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
- Class II
Medical Device Recall · January 25, 2024
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
- Unclassified
Consumer Product Recall · January 25, 2024
Pacific Cycle Inc., of Madison, Wisconsin
Ascend Cabrillo and Minaret Electric BikesThe wiring harness that manages the charging of the lithium-ion battery was not properly assembled, creating a risk of overheating and fire while charging.
- Unclassified
Consumer Product Recall · January 25, 2024
BRS Fuel BottlesThe portable fuel bottles do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child-resistant, posing a risk of burn and poisoning to children.
- Class II
Drug Recall · January 25, 2024
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.CGMP Deviations
- Class III
Drug Recall · January 25, 2024
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Class I
Food Recall · January 25, 2024
Utz Wavy Originals Potato Chips, Net WT. 2.75 oz (78g), UPC 0-41780-19014-7.Product may contain undeclared milk.
- Class II
Medical Device Recall · January 25, 2024
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cementDue to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
- Unclassified
Consumer Product Recall · January 25, 2024
Clark Core Services LLC, d/b/a Clark Associates, of Lancaster, Pennsylvania
Allegro plastic side chairsThe plastic chairs can break apart while in use, posing a fall hazard.
- Unclassified
Consumer Product Recall · January 25, 2024
Wuhannuoyunxindianzikejiyouxiangongsi (dba LordRoadS), of China
Yaomiao Children's Rhinestone Silver TiarasThe rhinestones embedded in the recalled tiaras contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.
- Class III
Drug Recall · January 25, 2024
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., NorDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Class II
Medical Device Recall · January 25, 2024
SW Bari Lift & Transfer, Model Number 38060000Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
- Class III
Food Recall · January 25, 2024
Healthprint Vitamin D3 5000 Dietary Supplement, 200 tablets, packaged in plastic bottle.Product is sub-potent for Vitamin D and label contains incorrect percent daily value.
- Class III
Food Recall · January 25, 2024
Banana Pepper Rings 16 FL OZ (1PT) 473ml UPC:4056489223863. Packaged in a glass jar with metal lid.Container integrity issued (punctured lid)
- Class II
Food Recall · January 25, 2024
L&B Beautiful Morning Glory Muffins. Product #49025. 4 muffins per container. Net Wt 14 oz. UPC 18169-49025.Foreign material (metal)
- Class I
Food Recall · January 25, 2024
Authentic Fresh to You Deluxe Triple Decker Club Net Wt. 8.8oz (254g). Product packaged in a plastic PET container.Undeclared egg
- Unclassified
Consumer Product Recall · January 25, 2024
Visual Comfort & Co., of Skokie, Illinois
Maverick Coastal 60-inch Outdoor Ceiling FansThe fan's blade can crack or break and fall off the unit, posing an impact injury hazard.
- Class II
Medical Device Recall · January 24, 2024
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullarProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
impression coping, repositionable, short, screw-retained, PF 4.0The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
- Class II
Medical Device Recall · January 24, 2024
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231SProducts not sterilized, sterility cannot be confirmed
- Class II
Food Recall · January 24, 2024
MUTTI Crushed Tomatoes; Polpa; Net Wt 27.9 OZ (1lb 11.9 OZ) 790g; UPC 85469300071Internal can lining is detaching from can into product.
- Class II
Medical Device Recall · January 24, 2024
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
- Class II
Medical Device Recall · January 24, 2024
TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric andProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defecProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica IM Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
- Class II
Medical Device Recall · January 24, 2024
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621SProducts not sterilized, sterility cannot be confirmed
- Class II
Medical Device Recall · January 24, 2024
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25SProducts not sterilized, sterility cannot be confirmed
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 12 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.