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

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

12151–12175 of 40112

  • ModerateFDA (Devices)·Z-1508-2022·2022-08-17

    Cholestech LDX cholesterol test cassettes require bilirubin interference label update

    Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

    Product
    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube)…
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-1401-2022·2022-08-10

    SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval

    North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.

    Product
    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2022·2022-08-10

    PRESTIGE RETRACTION GRASPER recalled due to potential weld separation

    The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.

    Product
    PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2022·2022-08-10

    Atellica CH Iron_2 Diagnostic Device Produces False Microalbumin Results from Reagent Carryover

    Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.

    Product
    Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2022·2022-08-10

    Endoscopic Grasper Instruments Recalled Due to Weld Separation Risk

    Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.

    Product
    PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1484-2022·2022-08-10

    E-100 Generator electrosurgical units recalled due to preventative maintenance oversight

    Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.

    Product
    The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2022·2022-08-10

    Merlin 2 PCS MER3400 programmer software recalled by St. Jude Medical

    St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.

    Product
    Merlin 2 PCS MER37000 programmer Model MER3400 software
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-1495-2022·2022-08-10

    Pacemaker Programmer Software May Display Overestimated Battery Longevity

    St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.

    Product
    Merlin PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-1499-2022·2022-08-10

    Craftmatic Model 1 Adjustable Bed Base Recalled for Separation Risk

    Craftmatic Industries is recalling the Model 1 Base for Dual Bed Configurations due to a potential for the bed bases to separate or slip apart. This defect could cause dual-configured beds to shift unexpectedly.

    Product
    Craftmatic Model 1 Base for Dual Bed Configurations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2022·2022-08-10

    Craftmatic Legacy Bed Base Recalled for Potential Separation Risk

    Craftmatic Industries recalls the Legacy Base for Dual Bed Configurations due to a potential for beds to separate or slip away from one another. The defect poses a risk of unintended bed movement.

    Product
    Legacy Base for Dual Bed Configurations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2022·2022-08-10

    UroLift System recalled for potential implant deployment failure

    Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.

    Product
    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1442-2022·2022-08-10

    NanoSight NS300 Medical Device Recalled for Laser Safety Noncompliance

    Malvern Panalytical is recalling 507 NanoSight NS300 units due to noncompliance with Class 1 laser safety requirements. The device may not meet established safety standards for laser-based instruments.

    Product
    NanoSight NS300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2022·2022-08-10

    Turbett Surgical Container TS1500: Unapproved Rework Processes

    Turbett Surgical, Inc. is recalling the Turbett Surgical Container TS1500 because the affected units were subject to unapproved rework processes. Seven units were distributed to healthcare facilities in Colorado, Florida, North Carolina, and Pennsylvania.

    Product
    Turbett Surgical Container, TS1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2022·2022-08-10

    Medtronic Sprinter OTW Catheter Luer marking shows incorrect balloon diameter

    Medtronic Sprinter OTW Model SPR2512W balloon catheter has incorrect balloon diameter printed on the Luer connection point: 2.25mm instead of correct 2.5mm. Correct specification appears on outer packaging.

    Product
    Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2022·2022-08-10

    Medline germicidal bleach wipes recalled due to stability failure

    Medline Micro-Kill Germicidal Bleach Wipes are being recalled nationwide due to stability failure affecting approximately 6.1 million wipes across multiple lot numbers.

    Product
    MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1492-2022·2022-08-10

    EkoSonic Endovascular Device Kit Mislabeled: Boston Scientific Recall

    Boston Scientific is recalling 10 units of the EkoSonic Kit endovascular device due to product mislabeling. Affected devices were distributed to medical facilities in 10 US states.

    Product
    EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1491-2022·2022-08-10

    Boston Scientific Recalls EkoSonic Endovascular Device Kit for Mislabeling

    Boston Scientific is recalling 10 EkoSonic Endovascular Device Kits due to mislabeling. The affected kits were distributed to healthcare facilities in 10 U.S. states.

    Product
    EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product…
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1395-2022·2022-08-03

    CereLink ICP Monitor recalled for out-of-range pressure readings

    Integra LifeSciences is recalling CereLink ICP Monitors due to electrical interference causing intracranial pressure readings to drift out of range. Affected devices may display an error message indicating sensor or extension cable failure.

    Product
    CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1397-2022·2022-08-03

    BD Intraosseous Needle Kits recalled for mechanical failure and safety defects

    BD Intraosseous Needle Kits have been recalled due to mechanical failures that could prevent emergency vascular access. Affected units nationwide and in Canada may experience stylet removal problems, safety mechanism failures, or driver malfunction.

    Product
    Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1376-2022·2022-08-03

    ABACUS TPN Calculation Software recalled for medication error risk

    Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.

    Product
    ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE)…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1480-2022·2022-08-03

    Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect

    Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2022·2022-08-03

    Abbott Alinity c Hemoglobin Reagent Kit may produce falsely elevated test results

    Abbott Laboratories is recalling the Alinity c Hemoglobin Reagent Kit because the ARCHITECT and Alinity c assays can generate falsely elevated Hemoglobin A1c results.

    Product
    REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1453-2022·2022-08-03

    NuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information

    NuVasive Simplify Disc cervical implants have UDI barcodes with incorrect Global Trade Item Numbers that may cause selection of the wrong device size during implant surgery.

    Product
    Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc…
    Category
    Medical Device
    Distribution
    10 states