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.

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

13101–13125 of 13816

  • HighFDA (Devices)·Z-2397-2021·2021-09-08

    TruMatch Surgical Instruments Recalled for Software Alignment Error

    DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.

    Product
    TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2395-2021·2021-09-08

    Surgical instrument software error may cause limb misalignment

    DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.

    Product
    TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2394-2021·2021-09-08

    CT Pin Guide Instruments Recalled for Software Imaging Alignment Error

    The TruMatch CT Pin Guide Kit is being recalled due to a software error that may misalign surgical guidance images, potentially affecting limb positioning during hip, knee, and ankle surgery. No injuries have been reported.

    Product
    TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2410-2021·2021-09-08

    COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories

    COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.

    Product
    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2021·2021-09-08

    Surgical alignment software error recalled in patient-specific orthopedic instruments

    DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.

    Product
    TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2399-2021·2021-09-08

    DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error

    DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2389-2021·2021-09-08

    Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure

    Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.

    Product
    Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2021·2021-09-08

    TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments

    DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2409-2021·2021-09-08

    Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution

    Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.

    Product
    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2021·2021-09-08

    Norton Arm Kit surgical device recall due to sterilization failure

    Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.

    Product
    Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2021·2021-09-08

    Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device

    Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.

    Product
    smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2406-2021·2021-09-08

    Monaco RTP System software defect may cause incorrect radiation therapy dose calculations

    Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.

    Product
    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2382-2021·2021-09-08

    FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk

    Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.

    Product
    EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2021·2021-09-08

    Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue

    Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.

    Product
    Merge Hemo, Software packages 10.2, 10.3, and 10.4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2380-2021·2021-09-08

    Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns

    Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.

    Product
    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2021·2021-09-08

    MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle

    MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.

    Product
    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2021·2021-09-08

    Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall

    Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.

    Product
    DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2021·2021-09-08

    Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure

    Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.

    Product
    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2021·2021-09-08

    Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure

    Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.

    Product
    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismafl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2021·2021-09-08

    CoolSculpting Elite System Software Error May Misreport Thermal Events

    The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.

    Product
    CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-2404-2021·2021-09-08

    Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment

    Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.

    Product
    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2021·2021-09-08

    COVID-19 diagnostic test distributed outside certified laboratory channels

    CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.

    Product
    CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by thei
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2365-2021·2021-09-08

    Palindrome RT Repair Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
    Category
    Medical Device
    Distribution
    0 states