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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11326–11350 of 13717

  • 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
  • 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-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
    53 states
  • 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-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-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
  • 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-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-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 la
    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 la
    Category
    Medical Device
    Distribution
    10 states
  • 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), 8300-3
    Category
    Medical Device
    Distribution
    0 states
  • 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, D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • HighFDA (Devices)·Z-1477-2022·2022-08-03

    Medical Device Kits Recalled for Leaking Isopropyl Alcohol

    Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.

    Product
    Z-1477-2022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2022·2022-08-03

    Blood Glucose Meter Recalled for Marketing Without FDA Clearance

    Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.

    Product
    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2022·2022-08-03

    Abbott Hemoglobin A1c Assay Recalled for Falsely Elevated Test Results

    Abbott Laboratories is recalling hemoglobin A1c test reagents used with ARCHITECT and Alinity c analyzers. The assay may produce falsely elevated A1c results, potentially affecting diabetes patient management.

    Product
    REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
    Category
    Medical Device
    Distribution
    43 states
  • 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-1475-2022·2022-08-03

    Medline skin prep kits recalled due to leaking isopropyl alcohol bottles

    Medline Industries is recalling 1,880 units of skin prep convenience kits with models DYNDP1127A and DYNDP1131 distributed nationwide due to leaking bottles of isopropyl alcohol.

    Product
    Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1459-2022·2022-08-03

    Da Vinci Clip Applier Recall: Risk of Unexpected Instrument Motion

    Intuitive Surgical is recalling 62,895 Da Vinci S/Si Clip Appliers worldwide due to potential unexpected motion from partial instrument disengagement. No injuries or illnesses have been reported.

    Product
    Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1466-2022·2022-08-03

    GE Centricity PACS Software fails to notify of exam study modifications

    GE Healthcare's Centricity PACS software version 7.0 SP0.0.4.7 does not alert users when previously verified imaging studies are modified, potentially causing clinicians to use outdated or changed data without awareness.

    Product
    Centricity PACS Software Version 7.0 SP0.0.4.7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2022·2022-08-03

    Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol

    Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.

    Product
    Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2022·2022-08-03

    AquaC UNO H Dialysis Machine Recalled Due to Electrical Shock Risk

    Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.

    Product
    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
    Category
    Medical Device
    Distribution
    Distributed nationwide