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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4176–4200 of 13543

  • HighFDA (Devices)·Z-0817-2025·2025-01-15

    GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.

    Product
    Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2025·2025-01-15

    Tec 820 ISO Anesthesia Vaporizers can deliver less anesthetic than dial setting

    GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide and globally.

    Product
    Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2025·2025-01-15

    3B Medical Oxygen Cannula Recall: Units Shipped After Expiration Date

    3B Medical recalled 5,010 Ultrasoft Oxygen Cannula units (Model O2U2012, Lot 20170403) distributed in Massachusetts and Arkansas because they were shipped after their expiration date.

    Product
    Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0820-2025·2025-01-15

    Citric acid dialysis concentrate recalled for incorrect case labeling

    Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.

    Product
    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0807-2025·2025-01-15

    Neptune Medical Suction Rovers Recalled Due to Loose Bolts

    Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.

    Product
    100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0816-2025·2025-01-15

    Tec 820 SEV Anesthesia Vaporizer Recalled for Inadequate Anesthetic Delivery

    GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.

    Product
    Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2025·2025-01-15

    Xhibit Telemetry Receiver software versions may cause unsolicited system shutdowns

    Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.

    Product
    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0804-2025·2025-01-15

    Smaxel Fractional CO2 Laser recalled for missing safety label and instructions

    IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.

    Product
    Smaxel Fractional CO2 Laser, a Class IV medical laser system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2025·2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0819-2025·2025-01-15

    AMT Mini Enteral Extension Set Recalled for Incorrect Connector Type

    Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.

    Product
    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0802-2025·2025-01-15

    VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve

    Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.

    Product
    VACUETTE SAFELINK, REF: 450210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2025·2025-01-15

    Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification

    Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.

    Product
    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0805-2025·2025-01-15

    Diagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling

    Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.

    Product
    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0782-2025·2025-01-08

    Medical Device Kits Recalled for Non-Sterile Surgical Components

    Medline Industries is recalling See DocMan custom convenience kits that contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 48,655 units were distributed worldwide.

    Product
    See DocMan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2025·2025-01-08

    Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise

    Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.

    Product
    Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0776-2025·2025-01-08

    Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2025·2025-01-08

    Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2025·2025-01-08

    Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination

    Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2025·2025-01-08

    3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation

    3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.

    Product
    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

    Product
    Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2025·2025-01-08

    Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled Due to Sterility Concerns

    Medline is recalling custom surgical procedure kits that contain non-sterile surgical supplies with potential for endotoxin contamination. The kits were distributed worldwide, including the United States, United Arab Emirates, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
    Category
    Medical Device
    Distribution
    Distributed nationwide