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.

21051–21075 of 21633

  • 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 (Drugs)·D-059-2013·2012-11-28

    Dr. Reddy's Quetiapine Fumarate Tablets Recalled for Dissolution Failure

    Dr. Reddy's is recalling Quetiapine Fumarate Tablets, 25mg, because they failed USP dissolution testing during stability studies.

    Product
    Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0276-2013·2012-11-21

    Progressive Medical Recalls Endoscopic Dissectors with Broken Sterile Seals

    Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors because some sterile packages had broken seals, potentially compromising sterility.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0277-2013·2012-11-21

    Synthes External Fixation Clamp Recalled for Incorrect MR Safety Labeling

    Synthes USA HQ, Inc. is recalling 8 units of External Fixation System Tube to Tube Clamps because the provided insert incorrectly states the product is MR safe, while the device is actually MR Conditional.

    Product
    Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-055-2013·2012-11-21

    Ameridose Recalls Non-Sterile Drug Products Due to GMP Deficiencies

    Ameridose LLC is voluntarily recalling all non-sterile products nationwide due to Good Manufacturing Practice (GMP) deficiencies. The recall was initiated in October 2012.

    Product
    All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0259-2013·2012-11-14

    AMS AdVance Male Sling System Recalled for Suture Degradation

    American Medical Systems is voluntarily recalling the AdVance Male Sling System because the resorbable suture may degrade before the 15-month shelf life expires.

    Product
    AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2013·2012-11-14

    Zimmer Recalls Dynesys Set Screws Due to Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Dynesys Set Screws manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Set screw M6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-043-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System

    Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is mislabeled.

    Product
    AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2013·2012-11-14

    Zimmer Recalls Dynesys HA Pedicle Screws Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys HA Pedicle screws manufactured before March 2010 due to reported discrepancies between product and patient labels.

    Product
    Dynesys¿ HA Pedicle + set screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2013·2012-11-14

    Zimmer MS-30 Sterile Shafts Recalled for Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for MS-30 Sterile Shafts due to discrepancies in reference and lot numbers.

    Product
    MS-30 Shaft, Sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0245-2013·2012-11-14

    Zimmer Recalls Tibial Plates Due to Patient Label Discrepancies

    Zimmer Inc. is correcting patient labels for NCB-PT tibial plates manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    NCB¿-PT lateral proximal 3 hole tibial plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2013·2012-11-14

    Alphatec Spine Recalls Polyaxial Screw Assemblies Due to Incorrect Length Marking

    Alphatec Spine is recalling 11 units of the TI Standard Polyaxial Screw Assembly because they were laser marked with the incorrect length of 45 MM.

    Product
    TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0254-2013·2012-11-14

    Sysmex XE-2100 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 1,099 XE-2100 Automated Hematology Systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2013·2012-11-14

    Zimmer Recalls Dynesys Universal Spacers Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys Universal Spacers manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Universal spacer 6-45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 133 mobile X-ray systems because certain units may not meet federal beam quality standards.

    Product
    0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0265-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 3 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Medical Device
    Distribution
    Distributed nationwide