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.

21326–21350 of 21633

  • ModerateFDA (Devices)·Z-2273-2012·2012-09-05

    Alphatec Recalls Trestle Luxe Anterior Cervical Plating System Components

    Alphatec Spine is recalling 38 units of the Trestle Luxe Anterior Cervical Plating System because the Slide Alignment Tool does not fit the plate screws.

    Product
    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2221-2012·2012-08-29

    GE Healthcare Recalls OEC 8800 Mobile X-ray Systems for Linearity Defect

    GE Healthcare is recalling 175 OEC 8800 Mobile Fluoroscopic X-ray Systems worldwide because they did not meet manufacturer specifications for linearity.

    Product
    GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2249-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a merger review.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1655-2012·2012-08-29

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 231,270 Daytrana patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1658-2012·2012-08-29

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1659-2012·2012-08-29

    Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Tests

    Prometheus Laboratories is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.

    Product
    Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2228-2012·2012-08-29

    Siemens Syphilis Assay Recalled Due to Interference with Hepatitis B Testing

    Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.

    Product
    Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2235-2012·2012-08-29

    Stryker Spine Recalls Instructions for Use Due to Sterile Marking Error

    Stryker Spine is recalling 40 units of Instructions For Use for TRIO+ Standard Post Screws because the front cover was incorrectly marked with a 'Sterile' logo.

    Product
    The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2224-2012·2012-08-29

    Biomet Oxford Gap Gauge Recalled Due to Drafting Error

    Biomet U.K., Ltd. is recalling 119 Oxford Gap Gauge instruments because a drafting error resulted in misleading dimensions on the product drawings.

    Product
    Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2225-2012·2012-08-29

    Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges

    Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.

    Product
    UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2248-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues in product documentation and classification identified during a merger review.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2229-2012·2012-08-29

    Sunquest Laboratory SMART Software Recall for Incorrect Patient Data

    Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.4.2 due to a defect that may display incorrect patient demographic data.

    Product
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1654-2012·2012-08-29

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 121,530 Daytrana patches because the release liner may be difficult to remove. The defect affects the patch's mechanical peel force.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2247-2012·2012-08-29

    Stryker Recalls Powered MOV Chairs for Documentation and Classification Issues

    Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a corporate merger.

    Product
    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2012·2012-08-29

    GE OEC Fluoroscopes Recalled for Snubber Board Safety Standard Non-Compliance

    GE OEC Medical Systems is recalling 845 fluoroscopes because the Snubber Board does not meet IEC 60601-1 safety standards for voltage isolation.

    Product
    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2222-2012·2012-08-29

    Conformis iTotal CR Knee Replacement System Recalled for Labeling Addendum

    Conformis Inc is recalling 1,427 iTotal CR Knee Replacement Systems to add a labeling addendum with detailed surgical instructions for poly insertion.

    Product
    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2016-2012·2012-08-29

    Spartan Sandwich Spread Recalled for Undeclared Yellow # 5 Dye

    Spartan Central Kitchen is recalling 4oz sandwich spreads because the label failed to declare Yellow # 5 as an ingredient.

    Product
    Spartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1652-2012·2012-08-29

    Victus Recalls Misbranded Hipoglos Ointment Tubes in Florida

    Victus, Inc. is voluntarily recalling 1,535 tubes of Hipoglos Ointment in Florida because the product is misbranded.

    Product
    Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g)…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2261-2012·2012-08-29

    Galil Medical Recalls Visual-ICE Cryoablation Systems Due to Gas Regulator Failure

    Galil Medical is recalling Visual-ICE Cryoablation Systems because gas regulators may fail, rendering the devices inoperable.

    Product
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2012·2012-08-29

    McKesson Horizon Medical Imaging System Recalled for Incorrect Report Status

    McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.

    Product
    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2012·2012-08-22

    Nico BrainPath Sheaths Recalled for Incorrect Length Labeling

    Nico Corp. is recalling 20 BrainPath sheaths because 50mm units were mislabeled as 60mm, creating a risk of improper fit during use.

    Product
    13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2184-2012·2012-08-22

    AGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data

    AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final reports.

    Product
    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2217-2012·2012-08-22

    DePuy Orthopaedics Recalls Unimplanted Custom Implant Devices

    DePuy Orthopaedics is retrieving 8,338 custom implant devices that were ordered but not implanted, following an FDA Warning Letter.

    Product
    DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2012·2012-08-22

    Nico BrainPath Sheath Recall Due to Incorrect Length Labeling

    Nico Corp. is recalling 15 BrainPath sheaths because 50mm units were mislabeled as 60mm, causing improper fit.

    Product
    13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2187-2012·2012-08-22

    Zimmer Recalls NCB Polyaxial Locking Plate System NCB Screws Due to Incorrect Size

    Zimmer, Inc. is recalling 26mm NCB Polyaxial Locking Plate System screws because a lot contained incorrect 32mm screws.

    Product
    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
    Category
    Medical Device
    Distribution
    Distributed nationwide