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

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

11826–11850 of 13802

  • HighFDA (Devices)·Z-1053-2022·2022-05-18

    Ethicon STRATAFIX Surgical Sutures Recalled for Incorrect Needle Type and Size

    Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.

    Product
    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1059-2022·2022-05-18

    VITEK 2 Systems Software Issue May Produce Incorrect Antibiotic Test Results

    bioMerieux VITEK 2 bacterial identification systems have a software defect where antibiotic susceptibility and synergy test results transmitted to laboratory systems may omit user or automated corrections, potentially leading to incorrect test interpretation.

    Product
    VITEK 2 Systems and VITEK 2 with MYLA.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1072-2022·2022-05-18

    Radial Head Replacement System implant: contraindications added to safety instructions

    Synthes has updated safety instructions for its Radial Head Replacement System implant with absolute contraindications for use in patients with infection, sepsis, or osteomyelitis. The FDA has classified this as a Class II recall.

    Product
    Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2022·2022-05-18

    Medtronic IN.PACT AV Balloon Catheter: Damaged Packaging May Affect Sterility

    Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.

    Product
    Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2022·2022-05-18

    Chemotherapy Infusion Bag Adaptor May Disconnect and Spill Hazardous Drugs

    Simplivia Healthcare is recalling OnGuard2 CSTD Bag Adaptors because they may disconnect from infusion bags, potentially spilling hazardous medications.

    Product
    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2022·2022-05-18

    Spine Surgery Instrument Sets Recalled for Sterilization Defect

    American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.

    Product
    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2022·2022-05-18

    KARL STORZ Nasopharyngolaryngoscope Disinfection Failure Affects 14 States

    The FDA is recalling KARL STORZ Slim Nasopharyngolaryngoscope models 11001RD1 and 11001RDK1 because they fail to achieve adequate disinfection, potentially allowing microorganisms to persist on the device and transmit between patients.

    Product
    11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2022·2022-05-18

    Surgical Device Kits Recalled Due to Improper Sterilization Process

    American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.

    Product
    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2022·2022-05-18

    Flexible Cystoscopes Recalled for Inadequate Disinfection Process

    Karl Storz Flexible Cystoscope units may not be properly disinfected because the disinfection process fails to achieve the expected reduction of microorganisms. All units manufactured since January 2018 are potentially affected.

    Product
    11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1048-2022·2022-05-18

    Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall

    Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.

    Product
    BF-MP160F: EVIS EXERA Bronchofibervideoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1051-2022·2022-05-18

    CABG Surgical Kit Recall Due to Improper Shipping Box Packing

    ROi CPS LLC is recalling 85 Regard brand CABG Packs due to incorrect packing into shipping boxes. One North Carolina healthcare facility received the affected kits.

    Product
    Regard brand CABG Pack A and B - Spartanburg
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1040-2022·2022-05-18

    ACS Cath Lab Packs Sterilized with Excess Ethylene Oxide

    American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.

    Product
    ACS Cath Lab Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1060-2022·2022-05-18

    First Aid Kits and Cabinets Recalled for Manufacturing Deviations

    Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.

    Product
    The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Fir
    Category
    Medical Device
    Distribution
    36 states
  • LowFDA (Devices)·Z-1056-2022·2022-05-18

    Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers

    Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.

    Product
    putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0944-2022·2022-05-11

    COVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization

    SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.

    Product
    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2022·2022-05-11

    Robotic-Assisted Medical Device Recalled Due to Software Defect

    The FDA is recalling the VELYS Robotic-Assisted Solution Base due to a software defect in version 1.5.1 related to Daylight Saving Time changes. The defect can cause system errors requiring restart, potentially delaying patient treatment.

    Product
    VELYS Robotic-Assisted Solution Base Product No.: 451570100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2022·2022-05-11

    Siemens ADVIA Centaur Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading clinicians to misinterpret patient results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2022·2022-05-11

    Restrata Medical Device Recall: Misprinted Expiration Date on Shelf-Box Packaging

    Acera Surgical Inc is recalling 83 units of the Restrata RWM1-2X2 medical device (Lot Number 51745) due to a misprinted expiration date on the shelf-box packaging distributed nationwide.

    Product
    Restrata, Part Number RWM1-2X2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2022·2022-05-11

    Medical Device Software Update Overwrites Custom Antibiotic Codes

    BD Synapsys Microbiology Informatics Software version 4.10 overwrites customer-configured antibiotic codes with BD defaults during system updates, affecting data integrity in clinical microbiology reporting.

    Product
    BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2022·2022-05-11

    In Vitro Diagnostic Estradiol Test Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient results.

    Product
    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2022·2022-05-11

    Baxter Flo-Thru Intraluminal Shunt Recall for Potential Foreign Matter

    Baxter Healthcare is recalling Flo-Thru Intraluminal Shunts due to potential foreign matter contamination. The recall involves 300 devices distributed in the U.S. and internationally.

    Product
    Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0886-2022·2022-05-11

    Azurion Medical Imaging System Software Defect Alters Dose Parameters

    A software defect in Philips Azurion imaging systems causes the Patient Type to change unexpectedly during study initiation, altering dose control parameters without operator notification.

    Product
    Azurion systems with software release R1.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2022·2022-05-11

    Estradiol Diagnostic Test Recall: Risk of Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.

    Product
    Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2022·2022-05-11

    Estradiol Diagnostic Device Recalled for Falsely Elevated Test Results

    An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.

    Product
    ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
    Category
    Medical Device
    Distribution
    Distributed nationwide