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

Category

Minimum severity

Clear filters

9226–9250 of 13652

  • HighFDA (Devices)·Z-1681-2023·2023-06-14

    Surgical anchor inserter recalled for potential tip fracture and bone damage

    DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2023·2023-06-14

    QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk

    Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2023·2023-06-14

    BD Veritor System Instructions for Use Not FDA Approved

    The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.

    Product
    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2023·2023-06-14

    SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter

    Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.

    Product
    SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2023·2023-06-14

    Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk

    Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.

    Product
    Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2023·2023-06-14

    AVNS ambIT System infusion kits recalled for missing air filter

    Avanos Medical is recalling certain AVNS ambIT System infusion kits because some units may lack the required air in-line filter. Affected kits were distributed worldwide including the US (Texas and Oregon) and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2023·2023-06-14

    AVNS ambIT Catheter System Kits Recalled for Missing Air Filter

    Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2023·2023-06-14

    DePuy Mitek surgical anchor inserter tip may fragment and be retained

    DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2023·2023-06-14

    Magic3 Go Female Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1691-2023·2023-06-14

    Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers

    DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.

    Product
    Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2023·2023-06-14

    Magic3 Go Pediatric Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1699-2023·2023-06-14

    Magic3 Go Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.

    Product
    Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2023·2023-06-14

    Avanos Recalls ambIT Cassette Filters for Missing Air In-Line Filter

    Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.

    Product
    ambIT Cassette Filter Male Luer, Product Code: 220266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2023·2023-06-14

    DePuy Mitek surgical anchor inserter may fracture during use

    DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.

    Product
    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2023·2023-06-14

    DePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery

    DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2023·2023-06-14

    TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size

    Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.

    Product
    The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2023·2023-06-14

    Surgical Procedure Packs Recalled Due to Included Light Handle Covers

    DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.

    Product
    Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2023·2023-06-14

    Surgical Anchor Inserter Tip Fragmentation During Patient Procedures

    DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2023·2023-06-14

    Presource Laparoscopy Kit Recalled for Lack of Sterility Assurance

    Cardinal Health is recalling Presource Kit laparoscopy surgical packs due to being released without sterility assurance. Affected units may harbor contamination and pose a risk during surgical procedures.

    Product
    Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1676-2023·2023-06-14

    Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results

    BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.

    Product
    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2023·2023-06-14

    Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter

    Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.

    Product
    SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1695-2023·2023-06-14

    ESR Diagnostic Control Vials Recalled for Incorrect Lot Labeling

    Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.

    Product
    RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1701-2023·2023-06-14

    HydroSil Go Catheters Recalled for Packaging Sterility Risk

    C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.

    Product
    HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1697-2023·2023-06-14

    Fluoride Varnish Packaging Error: Wrong Flavor Variant in White Mint Package

    Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.

    Product
    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1694-2023·2023-06-14

    ESR Diagnostic Quality Control Material Incorrectly Labeled as Different Level

    RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.

    Product
    RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
    Category
    Medical Device
    Distribution
    Distributed nationwide