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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9376–9400 of 27441

  • HighFDA (Devices)·Z-1821-2022·2022-10-05

    OSSUR Power Knee Prosthetics Recalled for Battery Dislodgement Risk

    OSSUR Power Knee prosthetics are being recalled because the battery may dislodge from the device. Approximately 190 units are affected across the United States.

    Product
    OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
    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-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-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-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-1836-2022·2022-10-05

    Cook Newton Wire Guide Recalls Due to Potential Sterility Compromise

    Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires because packaging seals may be breached, potentially compromising device sterility.

    Product
    Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
    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-1854-2022·2022-10-05

    Barco Medical Network Adapter Recalled for Installation Issues

    Barco NV recalls 169 NexxisOR system network adapters (models K9303078A and K9303097A) due to installation issues. The affected devices were distributed in Florida, Illinois, and New Jersey.

    Product
    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
    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-1816-2022·2022-10-05

    Siemens Magnesium Test Cartridges May Produce Erroneous Results Without Alert

    Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.

    Product
    Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
    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-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-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-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-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-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-1837-2022·2022-10-05

    Cook Roadrunner PC Guidewires Recalled for Compromised Packaging Sterility

    Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.

    Product
    Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2022·2022-10-05

    Humidifier Bottle and Syringe Filter Kit Sterile Barrier Breach Recall

    CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.

    Product
    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
    Category
    Medical Device
    Distribution
    25 states
  • 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-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-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-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-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-1835-2022·2022-10-05

    Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach

    Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.

    Product
    Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
    Category
    Medical Device
    Distribution
    Distributed nationwide