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

Clear filters

12626–12650 of 13802

  • HighFDA (Devices)·Z-0229-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades recalled for specification mismatch

    Beaver Visitec is recalling CustomEyes surgical kits where Crescent Knives contain bevel-up blades instead of the specified bevel-down blades. The specification error could affect surgical precision during cataract procedures.

    Product
    bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2022·2021-11-24

    Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues

    Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.

    Product
    BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2022·2021-11-24

    Beaver Xstar Crescent Knife Surgical Blades Recalled for Wrong Blade Orientation

    Beaver Visitec International recalls CustomEyes Cataract Surgical Kits containing Xstar Crescent Knives with incorrect blade orientation. Kits labeled as 55-degree bevel-down blades actually contain bevel-up blades.

    Product
    bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2022·2021-11-24

    Out-of-Specification Swabstick Recalled in REGARD Stereotactic Tray

    ROi CPS LLC recalled REGARD Stereotactic Trays due to out-of-specification Povidone-Iodine swabstick components. The recall affects 175 units distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Stereotactic Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation

    Cordis Corporation is recalling the SMART FLEX Biliary Stent System (Lot 266586) due to potential distal tip dislodgement or separation. Affected units were distributed to select US states and Canada.

    Product
    SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0218-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System recalled for potential tip separation

    Cordis is recalling the SMART FLEX 6x150 BIL biliary stent system due to potential separation of the distal tip. Approximately 26 units were distributed in the U.S. and Canada. Affected patients should contact their healthcare provider.

    Product
    SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0227-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle

    Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.

    Product
    Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2022·2021-11-24

    FDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk

    Cordis Corporation is recalling 9 SMART FLEX 9x60 biliary stent units due to a potential for distal tip dislodgement or separation. The stents were distributed to patients in several U.S. states and Canada.

    Product
    SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0221-2022·2021-11-24

    SMART FLEX Biliary Stent System Recalled for Potential Distal Tip Dislodgement

    Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL biliary stent system (Lot No. 271626) due to a potential for distal tip dislodgement or separation. The affected units were distributed in the US and Canada.

    Product
    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0255-2022·2021-11-24

    REGARD Ultrasound Trays Recalled for Out-of-Specification Swabstick Component

    ROi CPS LLC has recalled REGARD Ultrasound Trays because they contain out-of-specification Povidone-Iodine swabstick components. The 240 affected trays were distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Ultrasound Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2022·2021-11-24

    LEEP PRECISION Electrosurgical System Coagulation Function May Fail

    CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.

    Product
    LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2022·2021-11-24

    Smith & Nephew EVOS Self-Tapping Locking Screws recalled due to switched package labels

    Smith & Nephew is recalling 224 units of EVOS Self-Tapping Locking Screws because package labels were switched, creating a risk that incorrect screw sizes could be implanted during surgery.

    Product
    Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0245-2022·2021-11-24

    Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect

    Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.

    Product
    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0223-2022·2021-11-24

    Transseptal Needle with Catheter Recalled Due to Rust Contamination Risk

    Cook Inc. is recalling transseptal needles that may contain rust on internal or external surfaces. If used, the rust could cause increased procedural time or inflammatory reactions, potentially leading to systemic complications.

    Product
    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0222-2022·2021-11-24

    Transseptal Needles Recalled Due to Rust Contamination Risk

    Cook Inc. is recalling transseptal needles that may contain undetected rust, which could cause inflammatory reactions, systemic responses, and potentially permanent impairment.

    Product
    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2022·2021-11-24

    Bodycad Torque Limiting Adaptor Recalled for Breakage Risk

    Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.

    Product
    Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0262-2022·2021-11-24

    Electrosurgical Generator Coagulation Function May Fail During Surgery

    CooperSurgical recalled 700 Quantum 2000 Electrosurgical Generators due to a hand switch coagulation function defect that may fail to operate during surgery, potentially requiring medical intervention to control intraoperative bleeding.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2022·2021-11-24

    Quantum 2000 Electrosurgical Generator Hand Switch Coagulation Failure

    CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2022·2021-11-24

    Syphilis Test Reagent Pack Recalled Due to False Positive Results

    Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

    Product
    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or ti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2022·2021-11-24

    LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure

    CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.

    Product
    LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2022·2021-11-24

    Surgical Crescent Knife Recalled for Incorrect Blade Orientation Labeling

    Beaver Visitec International is recalling bvi CustomEyes Kits containing Crescent Knives due to incorrect labeling. Products labeled as 55-degree bevel-down blades actually contain bevel-up blades.

    Product
    bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2022·2021-11-24

    SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement

    Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.

    Product
    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0250-2022·2021-11-24

    REGARD Basic Cataract Tray Recalled for Out-of-Specification Component

    ROi CPS LLC is recalling 126 REGARD Basic Cataract trays because a Povidone-Iodine swabstick component is out of specifications. Affected trays were distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Basic Cataract tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0248-2022·2021-11-24

    Reproductive Medical Device Recalled for Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze, a medical device used in assisted reproductive procedures, due to kit components being labeled with incorrect expiration dates.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2022·2021-11-24

    FDA Class II Quantum 2000 Electrosurgical Generators Voluntary Recall

    CooperSurgical is voluntarily recalling 154 Quantum 2000 Electrosurgical Generators under FDA Class II classification. The specific reason for recall is not documented in available source information.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
    Category
    Medical Device
    Distribution
    Distributed nationwide