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 the agency’s own highest classification or reported deaths or serious injuries, 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.

Filters

Agency

Category

Minimum severity

Clear filters

16476–16500 of 40248

  • ModerateFDA (Devices)·Z-2971-2020·2020-09-23

    Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error

    Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.

    Product
    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2981-2020·2020-09-23

    Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim

    Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.

    Product
    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues

    Tosoh Bioscience is recalling five lots of AIA-PACK HCG Calibrator Sets because decreased stability may cause measured HCG concentrations to be up to 20% lower than actual.

    Product
    Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2958-2020·2020-09-23

    Boston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems

    Boston Scientific is recalling 40 units of WallFlex Biliary RX stents that were mislabeled as fully covered devices. The error involves the 10mm x 60mm size.

    Product
    WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2020·2020-09-23

    Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection

    Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.

    Product
    Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2968-2020·2020-09-23

    Tosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues

    Tosoh Bioscience is recalling 39 boxes of AIA-PACK BHCG Calibration Sets due to decreased stability that may cause inaccurate HCG concentration measurements.

    Product
    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2980-2020·2020-09-23

    Medtronic Guardian Connect iOS App Recall Due to Data Upload Failure

    Medtronic is recalling the Guardian Connect iOS app because a software update stopped automatic data uploads to the CareLink Personal website.

    Product
    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2962-2020·2020-09-23

    Randox Lactate Dehydrogenase Reagent Recalled for Carryover Avoidance Steps

    Randox Laboratories is recalling Lactate Dehydrogenase reagents to update technical bulletins with additional pipette wash steps to prevent reagent carryover and erroneous test results.

    Product
    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2977-2020·2020-09-23

    Oxford Immunotec T-SPOT.TB50 Tuberculosis Test Kits Recalled for Labeling Error

    Oxford Immunotec is recalling T-SPOT.TB50 tuberculosis test kits due to incorrect expiration dates on the test kit and substrate labels.

    Product
    Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2957-2020·2020-09-23

    Maquet Rotaflow System Console Instructions for Use Recall

    Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.

    Product
    Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2976-2020·2020-09-23

    Oxford Immunotec Recalls T-SPOT.TB8 Kits Due to Incorrect Expiration Dates

    Oxford Immunotec is recalling 583 T-SPOT.TB8 test kits because they have incorrect expiration dates on the labeling.

    Product
    Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2909-2020·2020-09-16

    CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect

    CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication infusions.

    Product
    Alaris System PC Unit Model 8015
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2910-2020·2020-09-16

    CareFusion PC Unit Front Case with Keypad Replacement Kits Recalled

    CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits because fluid ingress may cause keys to become unresponsive or stuck, potentially delaying or interrupting life-sustaining infusions.

    Product
    PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2939-2020·2020-09-16

    CareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects

    CareFusion is recalling BD Alaris infusion pumps because fluid ingress can cause unresponsive or stuck keys, potentially delaying or interrupting infusions.

    Product
    BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2938-2020·2020-09-16

    Qiagen SARS-CoV-2 Test Panel Recalled for Influenza A False Positives

    Qiagen is recalling 1,474 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to an increased rate of false positive results for Influenza A, which may lead to inappropriate antiviral use or delayed diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2950-2020·2020-09-16

    Intuitive Surgical Recalls ION Reprocessing Accessories Kit Due to Catheter Failure Risk

    Intuitive Surgical is recalling 27 units of the ION Reprocessing Accessories Kit because the catheter reprocessing cover may disengage, causing chemical retention and system failure.

    Product
    ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2949-2020·2020-09-16

    Intuitive Surgical Recalls Ion Catheter Reprocessing Covers

    Intuitive Surgical is recalling 67 Ion Catheter Reprocessing Covers because they may fail to engage correctly, potentially causing catheter or system failure.

    Product
    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2882-2020·2020-09-16

    CareFusion Recalls BD Alaris Modules for Incorrect Syringe Display

    CareFusion 303, Inc. is recalling BD Alaris Syringe and PCA Modules because they may display incorrect syringe types or sizes, potentially causing infusion errors.

    Product
    BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2946-2020·2020-09-16

    Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Incorrect Size Labeling

    Smiths Medical ASD Inc. is recalling three Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes because the labels display the incorrect size. The units were distributed in Connecticut.

    Product
    Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2940-2020·2020-09-16

    Medcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size

    Medical Components, Inc. is recalling 132 Medcomp Titan HD catheter kits because they were packaged with a 15F valve instead of the correct 16F valve.

    Product
    Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2943-2020·2020-09-16

    Talladium Luminesse Zirconia Discs Recalled for Incorrect Shrinkage Labeling

    Talladium Inc is recalling 39 Luminesse Zirconia Discs because the linear shrinkage value on the label is incorrect and outside the acceptable range.

    Product
    Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2937-2020·2020-09-16

    Hager & Meisinger Recalls Dental Burs Due to Labeling Discrepancy

    Hager & Meisinger is recalling 144 units of SINGLES Carbide dental burs because the US dates on the package label do not match the bar code display.

    Product
    SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2020·2020-09-16

    Smith & Nephew Recalls EVOS Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 71 units of EVOS Screws because the labels contain multiple or incorrect expiration dates.

    Product
    EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    0 states