The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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7326–7350 of 27393

  • HighFDA (Devices)·Z-2276-2023·2023-08-09

    OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall

    The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.

    Product
    OEC 9800 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2023·2023-08-09

    OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement

    GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.

    Product
    OEC Flexiview 8800 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2023·2023-08-09

    Custom Sterile Procedural Kits Recalled for Potential Sterility Specification Failure

    Medline is recalling 6,340 custom sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications, creating contamination risk in surgical applications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2314-2023·2023-08-09

    Medline procedural kits with potentially non-sterile ultrasound gel recalled

    Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2023·2023-08-09

    Medline procedural kits may contain non-sterile ultrasound gel

    Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Potential Sterility Failure

    Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2023·2023-08-09

    Intraocular Lenses Recalled Due to Unintended Fiducial Marks

    Johnson & Johnson is recalling 61 TECNIS Eyhance intraocular lenses that may have been manufactured with unintended toric fiducial marks, which could affect proper surgical positioning. The affected units were distributed to China, India, and Korea.

    Product
    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2303-2023·2023-08-09

    Medline procedural kits recalled for ultrasound gel sterility defect

    Medline recalls 100,549 procedural kits because the sterile ultrasound gel component may not meet sterility specifications. No illnesses or injuries have been reported.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure

    Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2259-2023·2023-08-09

    Incisive CT Computed Tomography System: Metal Mounting Box May Detach

    A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.

    Product
    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2023·2023-08-09

    Medical procedural kits recalled for potential sterile ultrasound gel defect

    Medline is recalling 93,587 custom procedural kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2023·2023-08-09

    ProPlan CMF Mandible Surgical Guides Recall for Wrong Version

    Materialise recalls ProPlan CMF mandible surgical guides because wrong versions were shipped prior to a redesign. Healthcare facilities should verify they have the correct version.

    Product
    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2023·2023-08-09

    Cardiac Surgery Device Blade May Fail to Latch Securely During Use

    The ACROBAT SUV blade may not latch securely onto its activator drive during use. This could prevent heart stabilization during surgery, cause positioning loss, or release device components into the patient.

    Product
    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2023·2023-08-09

    Medline procedural kits recalled for potential sterility failure in ultrasound gel

    Medline Industries is recalling 148,445 procedural kits containing Turkuaz Ultrasound Gel over potential sterility failure of the gel component, which could lead to infections if used in sterile procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2023·2023-08-09

    Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements

    Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Defect in Ultrasound Gel

    Medline Industries is recalling custom procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed nationwide and internationally from 2020 to 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2023·2023-08-09

    NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk

    NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.

    Product
    NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2023·2023-08-09

    Procedural Kits with Ultrasound Gel May Not Meet Sterility Specifications

    Medline Industries is recalling 144 custom procedural kits containing Turkuaz Ultrasound Gel because the sterile gel component may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2023·2023-08-09

    FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure

    Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2023·2023-08-09

    SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays

    Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2023·2023-08-09

    Medline Surgical Procedural Kits Recalled Due to Sterility Concerns

    Medline Industries is recalling approximately 7,462 custom surgical procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall affects kits distributed worldwide since April 2020.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2023·2023-08-09

    Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution

    Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.

    Product
    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2328-2023·2023-08-09

    Medline Procedural Kit Ultrasound Gel Sterility Specification Failure

    Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2023·2023-08-09

    Medical X-ray Systems Image Intensifier Detachment Injury Risk

    GE OEC Elite Systems with 9-inch Image Intensifier devices may detach during movement if subjected to impact force, potentially causing injury to personnel and bystanders.

    Product
    OEC Elite Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide