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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39426–39450 of 40449

  • ModerateFDA (Devices)·Z-0427-2013·2012-11-28

    King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.

    Product
    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0332-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0197-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic systems due to a firmware issue affecting technique accuracy.

    Product
    GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Documentation Issues

    Superstat Corp is recalling 26,422 units of Modified Collagen Hemostatic Sponge because documentation verifying quarterly dose sterility audits is unavailable.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2013·2012-11-28

    Zimmer Recalls Slotted Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling a software update for the 3D B.40 clinical instrument because it may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0302-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 1,336 units of 3D B.40 software due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0328-2013·2012-11-28

    Biomerieux B.40 Software Update Recalled for Patient Information Mislabeling

    Biomerieux Inc is recalling 33 B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0320-2013·2012-11-28

    Biomerieux BacT/ALERT Combo Module Recalled for Software Mislabeling

    Biomerieux is recalling BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0333-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0323-2013·2012-11-28

    BioMerieux B.40 Dualt-ML Software Update Recalled for Mislabeling Risk

    BioMerieux is recalling B.40 Dualt-ML software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0396-2013·2012-11-28

    Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

    Zimmer, Inc. is recalling 56,516 provisional femoral heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0329-2013·2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0339-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Records

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0425-2013·2012-11-28

    King Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling 2,630 infant laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper ethylene oxide sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0310-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Mislabeling Patient Information

    BioMerieux is recalling 556 units of 3D B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0307-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 163 units of the 3D B.40 software update because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0334-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit Documentation Gaps

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation is missing to verify that required quarterly dose sterility audits were performed.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0301-2013·2012-11-28

    BioMérieux BacT/ALERT 3D 60 Recalled for Software Mislabeling Error

    BioMérieux is recalling 145 BacT/ALERT 3D 60 modules worldwide because a software error may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0337-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility Audit Documentation

    Superstat Corp is recalling Modified Collagen Hemostatic Sponges because documentation verifying quarterly dose sterility audits is unavailable.

    Product
    Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 29 units of the 3D B.40 USB-ML03 software update due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0313-2013·2012-11-28

    BioMérieux BTA3D Control Software Recall for Patient Mislabeling

    BioMérieux is recalling BTA3D Control software due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0402-2013·2012-11-28

    Kerr Recalls Freedom Cordless LED Light System Due to Warmth

    Kerr Corporation is recalling 1,330 Freedom Cordless LED Light Systems because an incorrect component may cause units to become warm to the touch.

    Product
    Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0429-2013·2012-11-28

    Horiba Medical Recalls Minotrol 16 Hematology Control Material

    Horiba Medical is recalling Minotrol 16 lot MX090 (Level High) due to reports of high hemoglobin recovery values.

    Product
    Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using…
    Category
    Medical Device
    Distribution
    Distributed nationwide