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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5201–5225 of 39844

  • HighFDA (Devices)·Z-0476-2025·2024-11-27

    FDA Recalls Posi-Stop Injection Needles Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (25 gauge) because some units contain debris in the needle shaft that blocks injection solution flow.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2025·2024-11-27

    Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy

    Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.

    Product
    Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2025·2024-11-27

    Abbott Navitor Heart Valve Recalled for Leaflet Deflection Manufacturing Defect

    Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.

    Product
    Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0506-2025·2024-11-27

    Z-800 Infusion System Recalled for Battery Depletion Risk

    Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.

    Product
    Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certifie
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0376-2025·2024-11-27

    Baxter MiniCap PD Transfer Set Recalled for Potential PCB Exposure

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2025·2024-11-27

    Acrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall

    Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.

    Product
    Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2025·2024-11-27

    Posi-Stop Injection Needle Recalled Due to Manufacturing Debris Blockage

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2025·2024-11-27

    Posi-Stop Injection Needle Recall Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0467-2025·2024-11-27

    Bard Marquee Biopsy Instruments Recalled for Potential Needle Detachment

    Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2025·2024-11-27

    Posi-Stop Injection Needles recalled for manufacturing debris blockage

    Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris that can block needle flow. Some units may contain debris in the inner sheath that prevents injection solutions from functioning properly.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect

    Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0381-2025·2024-11-27

    Baxter MiniCap PD Transfer Set Recalled for Potential Chemical Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2025·2024-11-27

    EnChroma Safety Glasses recalled for defective impact protection

    EnChroma Inc recalls 53 units of safety glasses with Rx indoor lenses that fail impact safety standards, posing a risk of eye injury. Affected models include Martinez Cx1 Indoor Rx, Summit Indoor Rx, and Martinez Black Cx Rx.

    Product
    EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2025·2024-11-27

    JuggerLoc/ToggleLoc 2.9mm Drill Guide Warping in Packaging

    Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.

    Product
    JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls found in similar devices.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2025·2024-11-27

    Maquet Cardiovascular Recalls Acrobat-i Positioners Due to Sterility Concerns

    Maquet Cardiovascular is recalling 14,338 Acrobat-i Positioners because manufacturing deviations compromised the sterile barrier, meaning sterility cannot be assured during the product's 2-year shelf life.

    Product
    Acrobat-i Positioner. Model Number C-XP-5000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2025·2024-11-27

    Ethicon Recalls Monocryl Sutures Due to Component Mix-Up

    Ethicon, Inc. is recalling 16,524 units of Monocryl sutures because a manufacturing error may result in incorrect needle types, sizes, or suture lengths.

    Product
    MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0501-2025·2024-11-27

    OrganOx metra Liver Perfusion System Recalled for Battery Damage

    OrganOx Ltd is recalling 20 metra liver perfusion systems because battery movement caused a cell to short against the retention bracket.

    Product
    OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0490-2025·2024-11-27

    Alcon anti-reflux valve tubing breakage recall due to improper use

    Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.

    Product
    a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0500-2025·2024-11-27

    Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues

    NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.

    Product
    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PREC
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0498-2025·2024-11-27

    Olympus Gastrointestinal Videoscope Drying Instructions Clarified

    Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.

    Product
    Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0310-2025·2024-11-20

    Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors

    Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.

    Product
    Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0303-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.

    Product
    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0304-2025·2024-11-20

    Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure

    Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide