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

13126–13150 of 13837

  • 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-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-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-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-2405-2021·2021-09-08

    Discectomy Device Kit Class II recall due to sterile barrier compromise

    Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.

    Product
    Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-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-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-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-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-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-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-2357-2021·2021-09-08

    Medical Imaging Software Bug May Cause Incorrect X-ray Exposure

    Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.

    Product
    CombiDiagnost R90 Software Version R1.0 and R1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • ModerateFDA (Devices)·Z-2361-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal

    Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2367-2021·2021-09-08

    Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements

    Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.

    Product
    Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2408-2021·2021-09-08

    FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

    Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

    Product
    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2370-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2358-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2372-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2371-2021·2021-09-08

    Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
    Category
    Medical Device
    Distribution
    0 states