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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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

9901–9925 of 13717

  • HighFDA (Devices)·Z-1107-2023·2023-02-15

    Surgical instrument tracker recalled for structural failure during use

    Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.

    Product
    TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2023·2023-02-15

    Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2023·2023-02-15

    Roche cobas Influenza Test Recall Due to False Negative Results

    Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.

    Product
    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2023·2023-02-15

    Smart Correction External Fixation Struts: Collar Release Pin May Back Out

    The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.

    Product
    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2023·2023-02-15

    Sterile Trach Pack procedure kits recalled due to blade puncture risk

    Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product sterility.

    Product
    TRACH PACK. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2023·2023-02-15

    Medline Sterile Procedural Trays recalled due to packaging defect risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2023·2023-02-15

    Sterile endoscopy trays recalled for potential blade packaging puncture

    Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2023·2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTEREC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    MEDLINE INDUSTRIES is recalling sterile surgical trays used in robotic and laparoscopic procedures because blades within the kits can puncture the outer foil packaging. The recall affects 1,212 cases (2,101 units) distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2023·2023-02-15

    Precision Delivery Sets recalled due to potential tubing detachment

    Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.

    Product
    Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk

    Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m. TO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2023·2023-02-15

    Blade Puncture Risk in Femoral Artery Sterile Procedural Trays

    Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination risk.

    Product
    FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2023·2023-02-15

    Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results

    Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.

    Product
    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2023·2023-02-15

    Sterile Procedural Trays recalled for potential blade puncture of packaging

    Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.

    Product
    Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Over Blade Puncture Risk

    Medline recalls sterile procedural trays because sterile blades may puncture the outer foil packaging, compromising device sterility. The 314-case recall affects hospitals in the US, Canada, Japan, Mexico, Panama, Turks & Caicos, and UAE.

    Product
    Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2023·2023-02-15

    Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled for Potential Packaging Puncture Risk

    Medline Industries is recalling approximately 27,563 units of sterile procedural trays used in surgery because sterile blades may puncture the outer foil packaging layer, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2023·2023-02-15

    Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging

    Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.

    Product
    SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1091-2023·2023-02-15

    Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture

    Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2023·2023-02-15

    Sterile Procedural Trays recalled due to potential sterile packaging puncture

    Medline Industries is recalling Sterile Procedural Trays (IM NAIL) because sterile blades may puncture the outer foil layer of sterile packaging, potentially compromising sterility. No illnesses or injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: IM NAIL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture

    Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2023·2023-02-15

    Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging

    Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.

    Product
    UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2023·2023-02-15

    Spinal Cement System Recalled for Incorrect Expiration Date

    TEKNIMED SAS is recalling HIGH V+ Spinal Cement System (236 units) due to mislabeling showing expiration date of February 28, 2027 instead of the correct date February 28, 2025.

    Product
    HIGH V+ Spinal Cement System REF T040321K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2023·2023-02-15

    Medline sterile procedural trays recalled for blade packaging puncture

    Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.

    Product
    LOCAL PACK. Sterile Procedural Tray.
    Category
    Medical Device
    Distribution
    Distributed nationwide