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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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

11001–11025 of 13748

  • HighFDA (Devices)·Z-1833-2022·2022-10-05

    Cook Medical Guidewire Recall: Packaging Seal Breach May Compromise Sterility

    Cook Incorporated is recalling Fixed Core Wire Guide devices due to a potential breach in the packaging seal that may compromise device sterility.

    Product
    Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2022·2022-10-05

    Cook Rosen Curved Wire Guide Recall: Sterility Concerns

    Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.

    Product
    Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2022·2022-10-05

    YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall

    Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.

    Product
    Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1853-2022·2022-10-05

    YelloPort Plus 5x70 Cannula recalled: labeled sterile but non-sterile

    YelloPort Plus 5x70 Cannula devices are labeled as sterile but are actually non-sterile. This mislabeling poses an infection risk for laparoscopic surgical patients.

    Product
    Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1848-2022·2022-10-05

    Leica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue

    Leica Microsystems is recalling 30 ARveo 8 surgical microscopes (Part Number 10449063) distributed nationwide due to a photodiode component change causing inaccurate illumination adjustment when using the BrightCare Plus Luxmeter feature.

    Product
    Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2022·2022-10-05

    Cook guidewires recalled for compromised sterility due to packaging breach

    Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.

    Product
    Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2022·2022-10-05

    VenaCure EVLT procedure kit fiber component fails dimensional specification

    Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.

    Product
    VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2022·2022-10-05

    Leica Surgical Operating Microscopes recalled for illumination adjustment defect

    Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.

    Product
    Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2022·2022-10-05

    Olympus POWERSEAL surgical sealer recalled for loose retention ring defect

    Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2022·2022-10-05

    VIDAS CMV IgM diagnostic test kits recalled for invalid calibrations

    bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.

    Product
    VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1815-2022·2022-10-05

    Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring

    Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2022·2022-10-05

    Siemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results

    Siemens is recalling IMMULITE 2000 and XPi Thyroid Stimulating Immunoglobulins test kits due to a -23% negative bias that may produce falsely low results, potentially delaying diagnosis of autoimmune thyroid disease.

    Product
    IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2022·2022-10-05

    Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction

    Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.

    Product
    Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2022·2022-10-05

    Medical Guidewire Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.

    Product
    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2022·2022-10-05

    Leica M530 Surgical Microscopes recalled for illumination adjustment defect

    Leica Microsystems is recalling 115 M530 surgical microscopes due to a photodiode component change that causes inaccurate illumination limit adjustment when using the BrightCare Plus feature with Luxmeter.

    Product
    Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2022·2022-10-05

    Collagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise

    Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.

    Product
    Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schuma
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1810-2022·2022-10-05

    Insulin Infusion Sets Recalled for Incorrect Dosing Information in Instructions

    Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.

    Product
    Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1841-2022·2022-10-05

    Roadrunner PC Wire Guide Recalled for Packaging Breach and Sterility Compromise

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2022·2022-10-05

    Bentson Wire Guide Devices Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.

    Product
    Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2022·2022-10-05

    t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management

    Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve the issues.

    Product
    t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1840-2022·2022-10-05

    Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2022·2022-10-05

    BD Pyxis MedBank Cabinet Software Update Prevents Drawer Access

    A software update for BD Pyxis MedBank medication dispensing cabinets contains an incompatible file that prevents Matrix drawers from opening, potentially delaying medication access in healthcare facilities.

    Product
    BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2022·2022-10-05

    Torq-Flex Wire Guide Guidewires Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically and internationally.

    Product
    Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2022·2022-10-05

    CooperSurgical incubator humidifier kit recall due to sterile barrier breach

    CooperSurgical is recalling 5,182 humidifier bottle and filter kits for BT37 Mark II incubators due to potential sterile barrier damage from packaging defects. This could result in use of unsterilized components, risking embryo contamination.

    Product
    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1834-2022·2022-10-05

    Cook Guidewire Devices Recalled for Packaging Defect and Sterility Compromise

    Cook Incorporated is recalling fixed core wire guide devices due to packaging defects that may compromise device sterility. Approximately 5,669 units were distributed in the US and 5,286 internationally.

    Product
    Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593
    Category
    Medical Device
    Distribution
    Distributed nationwide