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

10976–11000 of 13717

  • 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-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-1761-2022·2022-10-05

    NanoSight particle analyzer recalled for laser safety non-compliance

    Malvern Panalytical is recalling approximately 111 NanoSight LM10 instruments with LM12 modules nationwide due to non-compliance with Class I laser safety requirements. Users may be exposed to unsafe laser radiation.

    Product
    NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2022·2022-10-05

    Medline suction catheters recalled due to connector separation risk

    Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.

    Product
    MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2022·2022-10-05

    FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach

    Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.

    Product
    Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2022·2022-10-05

    Cope Nitinol Guidewire Recalled Due to Packaging Sterility Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) devices because the packaging's chevron seal may be completely breached, potentially compromising sterility. The recall affects 1,501 US units and 380 international units.

    Product
    Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2022·2022-10-05

    Laboratory Instrument Recalled for Class 1 Laser Safety Non-Compliance

    Malvern Panalytical is recalling 76 NanoSight LM10 laboratory instruments that do not comply with Class 1 laser safety requirements. The company is taking this action to prevent potential laser exposure risks.

    Product
    NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
    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-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-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-1779-2022·2022-10-05

    SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles

    SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.

    Product
    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1827-2022·2022-10-05

    Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.

    Product
    Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2022·2022-10-05

    Medline ClearPro Suction Catheter Connector May Separate During Use

    Medline ClearPro closed suction catheters may have a connector that separates from the device during patient suctioning. The malfunction affects 65,320 units distributed nationwide and internationally.

    Product
    MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/R
    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-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-1831-2022·2022-10-05

    Cook Medical Wire Guide Devices Recalled for Packaging Breach

    Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.

    Product
    Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2022·2022-10-05

    Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.

    Product
    Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
    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-1828-2022·2022-10-05

    Coons Interventional Guidewire Recall Due to Packaging Sterility Breach

    Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.

    Product
    Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2022·2022-10-05

    Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter

    Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.

    Product
    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
    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-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-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-1839-2022·2022-10-05

    Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal

    Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.

    Product
    Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2022·2022-10-05

    Insulin pumps recalled for software malfunctions affecting blood glucose control

    Tandem Diabetes Care is recalling 31,100 t:slim X2 insulin pumps due to software issues that could cause inaccurate insulin delivery, potentially leading to dangerous blood sugar levels. A software update is available to address 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