The Recall Desk

Archive

August 2024 recalls

595 recalls were announced in August 2024.

What the numbers show

Critical
16
Severe
134
High
374
Moderate
69
Low
2

Of the 595 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.

1–100 of 595

  • SevereNHTSA·24V646000·2024-08-30

    E-One Recalls Cyclone and Typhoon Vehicles Due to Crossmember Defect

    E-One is recalling 2022-2024 Cyclone and Typhoon vehicles because a broken engine crossmember can damage the cooling fan, potentially causing an engine stall and increasing crash risk.

    Product
    E-ONE — E-ONE CYCLONE II, CYCLONE N, TYPHOON N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·025-2024·2024-08-30

    Hickory Hollow Jerky Recalls Beef and Bacon Jerky Produced Without Inspection

    Hickory Hollow Jerky is recalling approximately 6,229 pounds of beef and bacon jerky produced without federal inspection. The products were distributed in five states and online.

    Product
    Hickory Hollow Jerky — Hickory Hollow Jerky Recalls Ready-To-Eat Jerky Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·24E074000·2024-08-30

    Alltrade Recalls Kilimanjaro E-bike Racks Due to Connection Point Cracking

    Alltrade Tools LLC is recalling Kilimanjaro E-bike racks sold at Costco because connection points may crack, causing the rack to fail and the bicycle to detach.

    Product
    EQUIPMENT:MECHANICAL:CARRIER/RACK recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalCPSC·24350·2024-08-29

    HALO 1000 Portable Power Stations Recalled for Fire and Burn Hazards

    About 5,740 HALO 1000 Portable Power Stations are recalled because their lithium-ion batteries can overheat and catch fire. One death from smoke inhalation and four fire incidents have been reported.

    Product
    HALO 1000 Portable Power Stations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24352·2024-08-29

    Glow in Dark Party Supplies Toy Sets Recalled for Battery Ingestion Hazard

    Glow in Dark Party Supplies Toy Sets sold on Amazon contain button cell batteries in Bunny Ears Headbands that can be easily accessed by children, posing a serious ingestion hazard. The sets violate federal battery-operated toy regulations.

    Product
    Glow in Dark Party Supplies Toy Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V644000·2024-08-29

    Altec Recalls 2024 Spray Trucks and Aerial Devices for Line Security Defect

    Altec is recalling 623 units of 2024 spray trucks and aerial devices because fuel or brake lines may not be properly secured, posing risks of brake failure or fire.

    Product
    ALTEC — ALTEC SPRAY TRUCK, TA CLASS, AT SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24351·2024-08-29

    Fisher-Price Dumbbell Toy Recalled for Choking Hazard

    Fisher-Price is recalling a plastic dumbbell toy sold in the Baby Biceps Gift Set because the gray caps on the ends can come off, posing a choking hazard to infants. The firm has received seven reports of the ends coming off but no injuries have been reported.

    Product
    Dumbbell toy sold with Baby Biceps Gift Set
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2636-2024·2024-08-28

    McGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion

    McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.

    Product
    McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2024·2024-08-28

    ClotTriever XL Catheter instructions updated to prevent device entrapment and embolism

    Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.

    Product
    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1788-2024·2024-08-28

    Meijer Dunking Cookies Recalled for Undeclared Milk Allergen

    Meijer Inc is recalling Meijer Dunking Cookies Chocolate Chip (10 oz) due to undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    MEIJER DUNKING COOKIES CHOCOLATE CHIP, 10oz in clear plastic container. UPC 7-13733-71297-2
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0641-2024·2024-08-28

    Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels

    Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.

    Product
    ACETAMINOPHEN ASPIRIN AND CAFFEINE — ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0638-2024·2024-08-28

    FDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter

    B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V643000·2024-08-28

    Volkswagen ID.4 passenger airbag inflator fasteners may be loose

    Volkswagen is recalling certain 2023-2024 ID.4 vehicles because the fasteners securing the passenger frontal airbag inflator may be loose, so the airbag may not deploy as intended.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0635-2024·2024-08-28

    FDA Recalls Acetaminophen Injection Due to Labeling Mix-up

    Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2637-2024·2024-08-28

    McGRATH MAC EMS Video Laryngoscope Battery Management System Recall

    Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.

    Product
    McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2669-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled Over Reported Sharpness Issues

    Alcon is recalling 11,676 ophthalmic surgical knives due to increased reports of sharpness defects. Affected units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2024·2024-08-28

    Testosterone Gel Recalled by Teva for Excessive Potency

    Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2024·2024-08-28

    Diagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing

    The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 units distributed worldwide.

    Product
    BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2024·2024-08-28

    IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction

    FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.

    Product
    IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1741-2024·2024-08-28

    KALO Chocolate Cake Gluten Free recalled for undeclared soy allergen

    KALO All Natural Chocolate Cake Gluten Free (84 slices) is recalled due to undeclared soy. Carrot cake slices were accidentally packaged in chocolate cake containers.

    Product
    All Natural KALO Chocolate Cake Gluten Free, UPC 8 53407 00418 4, Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2676-2024·2024-08-28

    Ophthalmic surgical knives recalled for blade sharpness defect

    Alcon Research LLC is recalling 7,108 ClearCut and A-OK ophthalmic surgical knives due to increased complaint reports about blade sharpness. The affected knives were distributed nationwide and internationally.

    Product
    Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2706-2024·2024-08-28

    Medline procedure kit has dimensional variation affecting canister fitting

    Medline is recalling 3400 units of ENDO medical procedure kits due to a dimensional variation that may cause difficulty fitting the kit into its outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Fit

    Medline is recalling 964 units of multiple medical procedure kits due to slight dimensional variations that may cause difficulty fitting components into the outer canister. No injuries or illnesses have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1742-2024·2024-08-28

    Shahzada Cinnamon Powder Recalled for Elevated Lead Content

    Shahzada brand Cinnamon Powder is being recalled due to elevated lead content detected in the product. The affected 7 oz packets were distributed in New York, Massachusetts, New Jersey, and Connecticut.

    Product
    Shahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200g); packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2653-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Potential Sharpness Issues

    Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2024·2024-08-28

    ClearCut Ophthalmic Knives Recalled for Sharpness Defect

    Alcon is recalling 18,726 ClearCut ophthalmic knives worldwide due to reports of inadequate sharpness. The defect could compromise surgical precision during eye surgery.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2024·2024-08-28

    Medline ENDO KIT procedure kits recalled for dimensional variation affecting fit

    Medline is recalling 2,588 ENDO KIT medical procedure kits worldwide due to dimensional variation that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled Due to Sharpness Defects

    Alcon is recalling ClearCut SB INTREPID 2.2 ANG ophthalmic surgical knives due to increased complaint reports about inadequate blade sharpness. The recall affects 35,199 units distributed across the United States and 41 other countries.

    Product
    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2656-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Issues

    Alcon Research LLC is recalling certain ophthalmic knives (20 Gauge V-Lance model) due to complaints about sharpness. The affected units may not function properly during eye surgery.

    Product
    Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2024·2024-08-28

    VITROS XT Chemistry Slides Recalled for Dust Contamination of Diagnostic Results

    Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.

    Product
    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery

    Alcon Research LLC is recalling 2,520 CLEARCUT HP2 DB ophthalmic knives due to increased reports of reduced sharpness. The affected lot 164RY1 was distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2024·2024-08-28

    Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall

    Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.

    Product
    Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2665-2024·2024-08-28

    Ophthalmic knives recalled for insufficient sharpness in surgical instruments

    Alcon is recalling specific ophthalmic knives due to an increase in complaints regarding insufficient sharpness. Affected units may not perform as intended during surgical procedures.

    Product
    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2675-2024·2024-08-28

    Ophthalmic surgical knives recalled due to reported sharpness defects

    Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2024·2024-08-28

    Medline medical procedure kits recalled for dimensional variation affecting canister fit

    Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Defect

    Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.

    Product
    Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2668-2024·2024-08-28

    Ophthalmic Knives Recalled for Sharpness Defects

    Alcon recalls A-OK ophthalmic knives for sharpness defects. Approximately 30,268 units distributed nationwide and internationally are affected.

    Product
    Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2716-2024·2024-08-28

    Philips Allura Xper Interventional Fluoroscopy Systems Recalled for Incorrect Bolt

    Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.

    Product
    Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2024·2024-08-28

    Rubbing Alcohol Recalled for Non-Sterile Water in Manufacturing

    ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.

    Product
    Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2648-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for blade sharpness defects

    Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.

    Product
    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2024·2024-08-28

    Alcon A-OK Ophthalmic Knife Recalled for Sharpness Defect

    Alcon is recalling A-OK ophthalmic knives due to an increase in reports of sharpness defects. The affected knives are used in eye surgery and may not perform as intended.

    Product
    Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2645-2024·2024-08-28

    ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness

    Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.

    Product
    Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2024·2024-08-28

    Alinity hq Analyzer May Generate Incorrect Blood Test Results

    Abbott's Alinity hq Analyzer has been recalled due to software issues that can produce incorrect blood cell counts and hemoglobin measurements in certain circumstances. No illnesses have been reported.

    Product
    Alinity hq Analyzer, REF: 09P68-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2711-2024·2024-08-28

    Medline neuro procedure kits recalled for dimensional fitting variation

    Medline is recalling 2,013 medical procedure kits due to a slight dimensional variation that may cause difficulty fitting into the outer canister. No injuries reported.

    Product
    Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2024·2024-08-28

    Baxter Spectrum Wireless Battery Modules May Fail to Document Infusion Status

    Baxter Spectrum Wireless Battery Modules may fail to automatically transmit infusion status information to hospital electronic medical records systems. The software issue affects 17,377 units nationwide.

    Product
    Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2664-2024·2024-08-28

    Ophthalmic knife sharpness defect recalled for increased complaints

    Alcon recalls 3,419 ophthalmic knives due to increased complaints about blade sharpness. The Class II recall affects the ClearCut SB INTREPID 2.2 ANG and related models distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2644-2024·2024-08-28

    Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results

    Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.

    Product
    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2024·2024-08-28

    Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects

    Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.

    Product
    Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2024·2024-08-28

    NeuroLogica GM60A Mobile X-Ray System Anti-Fall Arm Safety Failure Risk

    NeuroLogica has recalled its GM60A Digital Diagnostic Mobile X-Ray System due to potential failure of the anti-fall safety system in the device arm. The recall affects 31 units distributed nationwide.

    Product
    GM60A. Digital Diagnostic Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2024·2024-08-28

    Spectrum Wireless Battery Modules fail to auto-document infusion status

    Spectrum Wireless Battery Modules may fail to send infusion status updates to hospital electronic medical records. The issue affects 17,377 units nationwide used with Spectrum V8 and IQ infusion pumps.

    Product
    Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2657-2024·2024-08-28

    ClearCut Sideport Ophthalmic Knives Recalled Due to Sharpness Issues

    Alcon has recalled ClearCut Sideport Knife ophthalmic surgical instruments due to an increase in complaint reports related to sharpness.

    Product
    Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2698-2024·2024-08-28

    Medline Med-Soft Liners Recalled for Potential Fitting Difficulty

    Medline Industries is recalling approximately 35,900 Med-Soft Liners due to a dimensional variation that could make them difficult to fit into the outer canister. No injuries have been reported.

    Product
    1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2024·2024-08-28

    Alcon recalls ophthalmic knives due to sharpness defects

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to increased complaint reports related to blade sharpness. Healthcare providers should not use affected units pending further evaluation.

    Product
    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2024·2024-08-28

    Medline medical procedure kits recalled for dimensional variation

    Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2685-2024·2024-08-28

    Regard Kit Decanters Recalled for Defective Sterile Packaging

    ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.

    Product
    Regard Kit containing the Microtek decanter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2024·2024-08-28

    Ophthalmic Knives Recalled Due to Complaints About Reduced Sharpness

    Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2660-2024·2024-08-28

    Ophthalmic surgical knives recalled for increased reports of dulled blades

    Alcon recalls specific ClearCut and A-OK ophthalmic surgical knives after reports of reduced blade sharpness. About 7,598 units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1746-2024·2024-08-28

    Great Value Apple Juice Recalled for Inorganic Arsenic Contamination

    Refresco Beverages is recalling Great Value 8oz apple juice in 6-packs due to inorganic arsenic levels above FDA guidance. The recall affects approximately 9,535 cases distributed across multiple U.S. states and Puerto Rico.

    Product
    Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged in 8 oz. PET plastic bottles; UPC 0-78742-29655-5
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-1743-2024·2024-08-28

    El Chilar Ground Cinnamon Recalled Due to Elevated Lead Levels

    EL Chilar-HF, LLC is recalling El Chilar Canela Molida (Ground Cinnamon) due to elevated lead levels detected in samples tested by the Maryland Department of Health. Affected products were distributed in Maryland.

    Product
    El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , Spices Herbs, BOPP Bag, 12 units per cases
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1744-2024·2024-08-28

    L&B Beautiful Morning Glory Muffins Recalled for Metal Contamination

    Lunds Mitchell Rd LLC is recalling L&B Beautiful Morning Glory Muffins (Product #49025, Lot 301355) distributed in Minnesota due to potential metal contamination in the product.

    Product
    L&B Beautiful Morning Glory Muffins. Product #49025. 4 muffins per container. Net Wt 14 oz. UPC 18169-49025.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2651-2024·2024-08-28

    Ophthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB

    Alcon is recalling 1,152 ClearCut Safety Intrepid DB 2.2 ophthalmic knives (Model 8065772265) due to complaint reports of sharpness defects.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2666-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defect

    Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Sharpness Defects

    Alcon recalls TOTAL PLUS ophthalmic surgical knives due to sharpness defect complaints. The 3,197 affected units are distributed nationwide and internationally.

    Product
    Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0636-2024·2024-08-28

    Lidocaine HCl Injection Recall Due to Lack of Sterility Assurance

    Fagron Compounding Services is recalling Lidocaine HCl Injection due to lack of assurance of sterility. Four lot numbers distributed nationwide are affected with expiration date 10/14/2024.

    Product
    Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness

    Alcon is recalling 4,481 units of ClearCut and A-OK brand ophthalmic surgical knives due to complaint reports of inadequate sharpness. These instruments are used in eye surgery and may not perform as intended.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2670-2024·2024-08-28

    Alcon Recalls ClearCut Ophthalmic Knives Due to Reduced Sharpness

    Alcon is recalling 15,222 units of ClearCut Slit and A-OK ophthalmic knives due to reports of reduced sharpness. The devices are distributed nationwide and internationally across 45+ countries.

    Product
    Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2024·2024-08-28

    Barricaid Annular Closure Impactor recalled due to missing welds

    Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.

    Product
    Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2024·2024-08-28

    Alcon ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness

    Alcon is recalling ClearCut Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to reports of reduced blade sharpness. The recall affects 6,020 units distributed in the United States and internationally.

    Product
    Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2647-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness and performance degradation

    Alcon is recalling surgical instrument packs that include ClearCut and A-OK brand ophthalmic knives due to increasing complaints about sharpness loss. The affected knives could impact surgical precision during eye procedures.

    Product
    Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2662-2024·2024-08-28

    Alcon recalls ClearCut ophthalmic knives due to sharpness issues

    Alcon is recalling approximately 11,916 ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to complaints about blade sharpness. The affected units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2024·2024-08-28

    FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures

    BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling ophthalmic surgical knives (model 8065990002) due to increased complaint reports regarding sharpness. Approximately 9,384 units have been distributed domestically and internationally.

    Product
    Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2024·2024-08-28

    Bag Decanter II Medical Device Recalled for Sterile Packaging Defects

    Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.

    Product
    Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2649-2024·2024-08-28

    Alcon ClearCut S Ophthalmic Knives Recalled for Sharpness Complaints

    Alcon is recalling ClearCut S and A-OK ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 5,039 units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2674-2024·2024-08-28

    Alcon ophthalmic surgical knives recalled for sharpness defects

    Alcon Research LLC recalls ClearCut and A-OK ophthalmic surgical knives due to increased reports of sharpness issues that may affect surgical performance.

    Product
    Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled Due to Sharpness Complaint Reports

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.

    Product
    Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness Defect

    Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function as intended during surgical procedures.

    Product
    Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2672-2024·2024-08-28

    FDA Recalls Alcon Ophthalmic Knives for Decreased Blade Sharpness

    Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.

    Product
    Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2024·2024-08-28

    Ophthalmic Surgical Knives Recalled by Alcon Due to Sharpness Defects

    Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.

    Product
    Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2680-2024·2024-08-28

    Alcon Ophthalmic Knives Recalled Due to Sharpness Defect Complaint Increase

    Alcon is recalling ClearCut and A-OK Corneal/Scleral ophthalmic knives due to increased complaints about sharpness. The recall affects 6,972 units distributed nationwide and internationally.

    Product
    Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2024·2024-08-28

    BIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect

    BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.

    Product
    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2024·2024-08-28

    Vial Decanter Medical Device Recalled for Compromised Sterile Packaging

    Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.

    Product
    Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2707-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation

    Medline Industries recalled 3,539 medical procedure kits due to a dimensional variation that may prevent proper fitting into their outer storage canister. The FDA classified this as a Class II recall.

    Product
    Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2697-2024·2024-08-28

    Medline Medical Soft Liner Recall Due to Dimensional Variation

    Medline Industries recalls 1.5L medical soft liners due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 88,703 units distributed worldwide.

    Product
    1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2024·2024-08-28

    Clinical Chemistry Analyzer Software Issue Causes Delayed Results

    Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2704-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Canister Fitting Issues

    Medline is recalling 22,891 medical procedure kits because of a slight dimensional variation that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2700-2024·2024-08-28

    Medline Anesthesia Circuit Kits Recalled for Dimensional Variation

    Medline is recalling three models of anesthesia circuit kits due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 1920 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2024·2024-08-28

    Medline Dental Procedure Kits Recalled Due to Dimensional Variation

    Medline Industries is recalling certain dental procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 99 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2024·2024-08-28

    Medline medical procedure kits recalled due to dimensional variation

    Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2717-2024·2024-08-28

    Covidien McGRATH MAC Video Laryngoscope Instruction Update for Battery Handling

    Covidien is recalling the McGRATH MAC Video Laryngoscope to address battery handling information in its instructions. The recall affects devices distributed worldwide.

    Product
    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2710-2024·2024-08-28

    Medline Procedure Kits Recalled Due to Dimensional Fitting Issues

    Medline is recalling 160 medical procedure kits due to a dimensional variation that may make them difficult to fit into their outer canister. No injuries have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2687-2024·2024-08-28

    Dental Digital Analog Products Recalled for Out-of-Specification Rotation

    Preat Corp is recalling 185 dental digital analog products due to out-of-specification rotation affecting inspection accuracy. The devices are used in dental laboratories for visual inspection of abutments and restorations.

    Product
    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2714-2024·2024-08-28

    Medline Surgical Procedure Kits Recalled for Dimensional Fit Issue

    Medline is recalling 14,977 surgical procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2694-2024·2024-08-28

    Medline Soft Suction Canister Liner Recalled for Dimensional Variation

    Medline Industries recalls soft suction canister liners due to dimensional variation that may cause difficulty fitting the product into the outer canister. The issue affects units distributed worldwide.

    Product
    LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2024·2024-08-28

    HAND-I-SAN Hand Sanitizer Recalled for Manufacturing Process Deviation

    HAND-I-SAN No-Rinse Hand Sanitizer is being recalled due to manufacturing process deviations involving the use of non-sterile water in production. The product was distributed nationwide and to Canada.

    Product
    HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 374
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2696-2024·2024-08-28

    Medline Soft Liner Dimensional Variation May Affect Outer Canister Fit

    Medline Industries is recalling 1500ML soft liners due to dimensional variations that may make fitting into the outer canister more difficult. No injuries have been reported.

    Product
    1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2024.