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.

21001–21025 of 21633

  • ModerateFDA (Devices)·Z-0415-2013·2012-11-28

    Biomet Recalls Acetabular Shells Due to Label Color Code Conflict

    Biomet, Inc. is recalling 16 Ranawat/Burnstein Acetabular Shells because the label color code conflicts with the liner size.

    Product
    Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2013·2012-11-28

    BioMérieux 3D IND Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 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-0420-2013·2012-11-28

    King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling 2,630 adult silicone King LAD devices because sterilization indicators failed to change color as expected.

    Product
    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2013·2012-11-28

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

    BioMerieux is recalling 671 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-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0389-2013·2012-11-28

    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 and fit issues.

    Product
    Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2013·2012-11-28

    BioMérieux Software Update Recalled for Patient Information Mislabeling

    BioMérieux is recalling 205 software update kits for clinical instruments due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 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-0331-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Missing Sterility Audit Documentation

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

    Product
    Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. 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-0342-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled Due to Missing Sterility 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, 32mm Disc, 3.0%, Part# 9100-30. 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-0338-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for Sterility Audit 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, 4x4 Pledget, 3.0%, Part# 9102-00. 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-0426-2013·2012-11-28

    King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

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

    Product
    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0411-2013·2012-11-28

    Gyrus Acmi Recalls Contaminated Silicone Tympanostomy Tubes

    Gyrus Acmi is recalling one lot of tympanostomy tubes because the silicone was contaminated with ethylene vinyl acetate copolymer.

    Product
    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0416-2013·2012-11-28

    Zimmer Recalls Trilogy Acetabular System Shells Due to Missing Threads

    Zimmer, Inc. is recalling 95 units of the Trilogy Acetabular System Shell with Cluster Holes because they are missing polar hole threads. No injuries were reported.

    Product
    The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2013·2012-11-28

    BioMerieux BacT/ALERT Combo Module Recalled for Software Miscommunication

    BioMerieux is recalling 26 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 200291, 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-0340-2013·2012-11-28

    Superstat Modified Collagen Hemostatic Sponge Recalled for 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, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. 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-0394-2013·2012-11-28

    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 and fit issues.

    Product
    00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2013·2012-11-28

    Kerr Laser Loupes Recalled Due to Wipeable Laser Frequency Markings

    Kerr Corporation is recalling 639 Laser Loupes because the ink marking the laser frequency protection may wipe off, though the devices function correctly.

    Product
    The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2013·2012-11-28

    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
    . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2013·2012-11-28

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

    BioMerieux is recalling 12 kits 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-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 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-0421-2013·2012-11-28

    King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of adult silicone King LAD devices because sterilization indicators failed to change color as expected.

    Product
    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0706-2013·2012-11-28

    Beagle Bay Organics Raw Sauerkraut Recalled Due to Missing Mixer Bolt

    Cracker Industries, LLC is recalling 65 jars of Beagle Bay Organics Raw Sauerkraut, Kimchi because a bolt was found missing from the rotation mixer.

    Product
    Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0387-2013·2012-11-28

    Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up

    Stryker Howmedica Osteonics is recalling approximately 72 units of 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length.

    Product
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2013·2012-11-28

    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 USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0392-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

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

    Product
    00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2013·2012-11-28

    Siemens Dimension Vista Theophylline Cartridge Recalled for Abnormal Reaction Errors

    Siemens Healthcare Diagnostics is recalling Dimension Vista Theophylline cartridges due to 'Abnormal Reaction' errors triggered by atypical particle reagent aggregation.

    Product
    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2013·2012-11-28

    Biomerieux B.40 Software Update Recalled for Patient Mislabeling

    Biomerieux Inc is recalling 22 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-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients…
    Category
    Medical Device
    Distribution
    19 states