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 39824

  • HighFDA (Devices)·Z-1478-2025·2025-04-09

    Nasopore Nasal Dressing Recall Due to Breached Sterile Packaging

    Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.

    Product
    Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2025·2025-04-09

    Medtronic A820 myPTM Infusion Pump Software Shows Delayed Patient Response

    Medtronic is recalling the A820 myPTM Software Application used with SynchroMed infusion pumps because the app is taking longer than expected to respond to patient interactions. Approximately 4365 units are affected worldwide.

    Product
    A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2025·2025-04-09

    Clinical Chemistry Analyzer Recalled for Software Defect in Test Result Calculation

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to a software defect that prevents calculated test results from being recalculated when constituent tests are rerun, potentially delaying patient result reporting.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2025·2025-04-09

    Cordis Smart Control Vascular Stent Size Mismatch Recalled

    Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.

    Product
    Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1504-2025·2025-04-09

    Respiratory Diagnostic Cartridges Recalled for Risk of False Test Results

    Qiagen is recalling 445 QIAstat-Dx Respiratory Panel Plus cartridges due to faulty units that could produce false test results. Affected devices distributed to 12 US states should not be used.

    Product
    Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1470-2025·2025-04-09

    Nasopore nasal dressing may have compromised sterile packaging

    Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.

    Product
    Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2025·2025-04-09

    Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect

    Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.

    Product
    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2025·2025-04-09

    Ethicon Surgical Sutures Recalled Due to Silicone Curing Manufacturing Defect

    Ethicon Endo Surgery recalls approximately 1,080 surgical sutures due to silicone curing issues identified during manufacturing. The defect may affect suture performance during surgical use.

    Product
    PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall

    Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.

    Product
    Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1475-2025·2025-04-09

    Otopore Square Outer Ear Wound Dressing Recall for Sterility Seal Defect

    Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.

    Product
    Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2025·2025-04-09

    Hemopore nasal wound dressing packaging seal defect may compromise sterility

    Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.

    Product
    Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2025·2025-04-09

    Nasopore Standard Nasal Dressing Recalled Due to Sterility Seal Defects

    Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.

    Product
    Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2025·2025-04-09

    Phoroptor VRx Digital Refraction System head may become loose or detach

    Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.

    Product
    Phoroptor VRx Digital Refraction System Model Numbers: 16241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2025·2025-04-09

    Stryker nasal wound dressing recalled for defective sterile packaging seal

    Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.

    Product
    Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2025·2025-04-09

    Boppli Bedside Device Kit blood pressure monitor may fail to detect pressure changes

    Boppli bedside blood pressure monitors for infants may not adequately detect blood pressure changes due to vibratory noise. Affected monitors should be moved to patient's foot and ventilator lines kept away from the isolette.

    Product
    Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1481-2025·2025-04-09

    Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1485-2025·2025-04-09

    GE Healthcare Centricity Radiology RA600 and related imaging systems login vulnerability

    GE Healthcare is recalling Centricity Radiology RA600 and related imaging systems due to a security vulnerability allowing service login credentials to be identified, potentially exposing patient data to unauthorized access.

    Product
    GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1503-2025·2025-04-09

    Laboratory diagnostic reagent distributed with incorrect calibration value on package label

    Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D reagent (1,699 units) due to an incorrect International Sensitivity Index (ISI) value printed on the box. No illnesses or injuries have been reported.

    Product
    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1513-2025·2025-04-09

    Surgical Suture Needles Recalled Due to Manufacturing Defect

    Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.

    Product
    PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1390-2025·2025-04-02

    Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk

    Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.

    Product
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1396-2025·2025-04-02

    CVAC Aspiration System Requires Labeling Update for Pressure Risk

    The CVAC Aspiration System requires a labeling update to add safety instructions for high-viscosity kidney fluid. Continuing fluid inflow without adequate outflow can create dangerous intrarenal pressure imbalances.

    Product
    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage

    Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2025·2025-04-02

    Medline Procedure Kits With Defective Plastic Syringes Recalled

    Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.

    Product
    Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2025·2025-04-02

    Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk

    Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide