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 the agency’s own highest classification or reported deaths or serious injuries, 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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16301–16325 of 40287

  • HighFDA (Devices)·Z-0050-2021·2020-10-14

    Ra Medical Systems Recalls DABRA RA-308 Excimer Laser Units

    Ra Medical Systems is recalling 54 DABRA RA-308 Excimer Laser units because a taller wheel mounting may cause the device to fall over, potentially injuring users or patients.

    Product
    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2021·2020-10-14

    Bard Conquest PTA Balloon Catheter Recalled for Incorrect Balloon Size

    Bard Peripheral Vascular Inc is recalling 281 units of the Conquest PTA Balloon Dilation Catheter because some units contain a 5mm balloon instead of the labeled 6mm size.

    Product
    Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0071-2021·2020-10-14

    Skytron VGA to Fiber Converter Recall for Video Signal Failure

    Skytron is recalling 11 VGA to Fiber Converter units for the SkyVision Linx 300 system due to faceplate failures that cause video signal loss on secondary displays.

    Product
    VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0077-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 35 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0074-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement in patients.

    Product
    BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0053-2021·2020-10-14

    Ultradent PermaFlo Flowable Composite Recalled for Manufacturing Cross-Contamination

    Ultradent Products, Inc. is recalling PermaFlo Flowable Composite due to a potential manufacturing issue causing cross-contamination and non-homogeneity.

    Product
    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0057-2021·2020-10-14

    Zimmer Biomet Recalls Dual Mobility Vivacit-E Bearing Due to Sizing Error

    Zimmer Biomet is recalling 31 Dual Mobility Vivacit-E bearings because the outer package label indicates a different size than the implant inside.

    Product
    Dual Mobility Vivacit-E Bearing, Model Number 110031009
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0076-2021·2020-10-14

    Biomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 4 units of BellaTek abutments because the hex was misaligned by 30 degrees, preventing correct placement in patients.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0056-2021·2020-10-14

    Brainlab Ultrasound Navigation Software Recalled for Image Width Limitation

    Brainlab AG is recalling Ultrasound Navigation Software 1.0 and related integration software because the system does not support modifying the probe's image width.

    Product
    Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0052-2021·2020-10-14

    Siemens Troponin I Reagent Cartridge Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Dimension LOCI High Sensitivity Troponin I reagent cartridges due to positive bias in test results.

    Product
    Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0075-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Dental Abutments

    Biomet 3i is recalling 9 units of BellaTek Encode Definitive Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0078-2021·2020-10-14

    Biomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment

    Biomet 3i is recalling 10 units of BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Devices)·Z-0070-2021·2020-10-14

    Devicor Neoprobe GDS Control Unit Recalled for Software Version Mismatch

    Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.

    Product
    Neoprobe GDS Control Unit, Model Number NPCU3
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0035-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,875 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0004-2021·2020-10-07

    FDA Recalls Endo GIA Stapler Loading Units Due to Staple Formation Defect

    The FDA is recalling specific lots of Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0032-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,268 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0037-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,256 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0048-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb Fast Braided Absorbable Sutures due to a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0045-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,253 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. This defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3053-2020·2020-10-07

    ESAOTE Portable Ultrasound AC/DC Power Supply Recall for Overheating Risk

    ESAOTE is recalling AC/DC power supplies for specific portable ultrasound systems because the connector may heat up, generate smoke, and melt.

    Product
    AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0015-2021·2020-10-07

    Riverpoint Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling non-sterile Velosorb sutures that could compromise sterile fields and increase infection risk.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2021·2020-10-07

    FDA Recalls Endo GIA Auto Suture Units Due to Staple Formation Defects

    FDA is recalling Endo GIA Auto Suture Universal Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0031-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 1,264 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is…
    Category
    Medical Device
    Distribution
    Distributed nationwide