The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

20976–21000 of 21633

  • ModerateFDA (Food)·F-0733-2013·2012-12-05

    Nestle Coffee-Mate Creamer Recalled for Manufacturing Error Causing Acidity

    Nestle Professional is recalling specific lots of Coffee-Mate Original Liquid Creamer Singles due to a manufacturing error that causes the product to become acidic.

    Product
    Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self dispensing fiberboard box. Four fiberboard boxes are packaged in a case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0445-2013·2012-12-05

    Diamedix Recalls Is-anti-Sm Test Kits Due to Control Failure

    Diamedix Corporation is recalling 65 Is-anti-Sm Test Kits because the positive control recovered high out of specification.

    Product
    The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·12V560000·2012-12-04

    Dodge Durango Recalled for Incorrect Seating Capacity Labels

    Chrysler is recalling 2013 Dodge Durango vehicles with incorrect seating capacity labels that may overstate capacity, potentially increasing injury risk in a crash.

    Product
    DODGE — DODGE DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2013·2012-11-28

    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 IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an 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-0315-2013·2012-11-28

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

    BioMerieux is recalling 28 software updates for the 3D B.40 instrument due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 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-0321-2013·2012-11-28

    BioMerieux 3D IND ZIP-ML Software Update Recalled for Mislabeling

    BioMerieux is recalling 288 units of the 3D IND ZIP-ML software update because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 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-0398-2013·2012-11-28

    Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

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

    Product
    00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2013·2012-11-28

    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
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0312-2013·2012-11-28

    BioMerieux BTA3D Combo Software Recall for Patient Mislabeling

    BioMerieux is recalling 205 BTA3D Combo software kits worldwide due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 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-0418-2013·2012-11-28

    King Systems Recalls Infant Silicone Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 infant silicone laryngeal airway devices due to potential EtO sterilization indicator failures.

    Product
    KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2013·2012-11-28

    Microgenics Recalls Thermo Scientific Omni IMMUNE Immunoassay Controls Due to Stability Issues

    Microgenics is recalling Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO controls because internal testing showed reduced stability for CK-MS and Insulin.

    Product
    Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0305-2013·2012-11-28

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

    BioMérieux is recalling 250 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 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-0399-2013·2012-11-28

    Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

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

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0200-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling Brivo XR 285 and Optima XR series mobile radiographic systems due to a firmware issue affecting technique accuracy.

    Product
    GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2013·2012-11-28

    GE Healthcare Recalls Fetal Scalp Electrodes Due to Packaging Seal Issues

    Vital Signs Devices is recalling 126 cases of Corometrics Qwik Connect Plus Spiral Electrodes because 30 units had incomplete package seals and missing lot numbers.

    Product
    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2013·2012-11-28

    OrthoPediatrics Recalls 4.5mm PLEO Osteotomy Guide Instruments

    OrthoPediatrics Corp is recalling 24 units of the 4.5mm PLEO Osteotomy Guide because the device was not manufactured to design specifications and will not function as intended.

    Product
    4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0335-2013·2012-11-28

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

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

    Product
    Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. 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-0303-2013·2012-11-28

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

    BioMérieux is recalling 860 units of 3D B.40 software updates due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 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-0336-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation

    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, 2x2 Pledget, 1.5%, Part# 9105-00. 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 (Food)·F-0711-2013·2012-11-28

    Schoep's Recalls Toasted Butter Pecan Ice Cream Due to Packaging Error

    Schoep's Ice Cream Co. is recalling Toasted Butter Pecan ice cream packaged in Vanilla Bean containers due to a labeling error.

    Product
    Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0395-2013·2012-11-28

    Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

    Zimmer, Inc. is recalling MIS Slotted Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.

    Product
    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2013·2012-11-28

    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
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2013·2012-11-28

    ConMed Linvatec Recalls Sentinel Cannulated Drill Bits Due to Labeling Errors

    ConMed Linvatec is recalling specific lots of Sentinel Cannulated Drill Bits because of incorrect labeling on the packages.

    Product
    "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0309-2013·2012-11-28

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

    BioMerieux is recalling 620 units of 3D B.40 software updates because a software error may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 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-0318-2013·2012-11-28

    BioMerieux BacT/ALERT Control Module Recalled for Software Mislabeling

    BioMerieux is recalling BacT/ALERT Control Modules because a software issue may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Control Module, catalog number 210148, 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…
    Category
    Medical Device
    Distribution
    19 states