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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8601–8625 of 13683

  • HighFDA (Devices)·Z-2283-2023·2023-08-09

    X-ray Imaging System Carriage Bolts May Loosen or Break

    Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.

    Product
    Allura Xper FD10 and FD20. X-ray Imaging System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2023·2023-08-09

    OEC 9900 Systems Image Intensifier Detachment and Fall Risk

    GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.

    Product
    OEC 9900 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2023·2023-08-09

    Medline Recalls Procedural Kits Over Sterility Specification Failure

    Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2023·2023-08-09

    ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems

    A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.

    Product
    ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2023·2023-08-09

    Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction

    Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2023·2023-08-09

    MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction

    Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.

    Product
    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2023·2023-08-09

    Medline Probe Cover Kits recalled for potential sterility specification failure

    Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.

    Product
    Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2023·2023-08-09

    Medline Procedural Kits with Turkuaz Ultrasound Gel Recalled for Sterility Concerns

    Medline is recalling custom sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. The kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2023·2023-08-09

    Surgical Procedural Kits Recalled for Potential Sterility Specification Failures

    Medline Industries is recalling 16,143 custom surgical procedural kits because the sterile ultrasound gel component may not meet sterility specifications. The 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. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2023·2023-08-09

    VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect

    Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.

    Product
    VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
    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-2297-2023·2023-08-09

    Procedural kits containing Turkuaz ultrasound gel recalled for sterility failure

    Medline Industries recalls approximately 97,677 procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The affected kits were distributed worldwide from April 1, 2020 to April 28, 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Sterility Specification Failure

    Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRA
    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-2313-2023·2023-08-09

    Sterile Procedural Kits Recalled Due to Potential Ultrasound Gel Sterility Failure

    Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
    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-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-2294-2023·2023-08-09

    Medline Pediatric EP Pack Procedural Kits with Sterile Ultrasound Gel Defect

    Medline is recalling pediatric electrophysiology procedural kits because the ultrasound gel component may not meet sterility specifications. The recall affects 192 kits distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2023·2023-08-09

    STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk

    FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.

    Product
    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2023·2023-08-09

    Zimmer Periarticular Locking Plate recalled due to thread form defect

    Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.

    Product
    Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular cond
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2291-2023·2023-08-09

    Medline Anesthesia Procedural Kits Recalled for Potential Sterility Failure

    Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2023·2023-08-09

    Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns

    Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile 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. PROBE COVER PACK, Model Number: DYNDA1219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2023·2023-08-09

    X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts

    Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.

    Product
    Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
    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