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 8,651–8,700 of 15,362

Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipu
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 REF 471049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Drug Recall · December 19, 2024
West-Ward Columbus Inc
Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class III
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 470405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM, POTTS SCISSORS, IS4000 REF 470001
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Ortho-Clinical Diagnostics, INc.
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Descri
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,COBRA GRASPER,IS4000 REF 471190
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Consumer Product Recall · December 19, 2024
Chervon North America Inc., of Naperville, Illinois
SKIL 40V 5.0 Ah Lithium-Ion Batteries
The lithium-ion batteries can overheat, posing fire and burn hazards.
Unclassified
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Consumer Product Recall · December 19, 2024
Elongdi, of China
Elongdi Magnetic Building Sticks Sets
The recalled magnetic building sticks set violates the mandatory federal regulation for magnet toys posing an ingestion hazard. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.
Unclassified
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Drug Recall · December 19, 2024
Hikma Injectables USA Inc
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II
Medical Device Recall · December 19, 2024
Jinan Bodor Cnc Machine Co Ltd
Bodor P and C series laser cutting machines
Non-compliant laser products
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Medical Device Recall · December 19, 2024
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class II
Medical Device Recall · December 19, 2024
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class II
Drug Recall · December 19, 2024
Hikma Injectables USA Inc
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II
Food Recall · December 19, 2024
River Valley Ranch Ltd
River Valley Ranch & Kitchens Spinach Artichoke Dip Mix. net wt. 16 oz. (453g). UPC 6 92016-40021 1. Keep Refrigerated After Opening. 39900 60th Street, Burlington, WI 53105.
Underprocessing
Class III