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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21426–21450 of 40175

  • HighFDA (Devices)·Z-0745-2019·2019-01-23

    Bayer Medical Care Recalls MAVIG Portegra Overhead Counterpoise Systems

    Bayer Medical Care is recalling MAVIG Portegra and Portegra2 Overhead Counterpoise Systems because the head mount knob may not be properly tightened, causing the injector head to become loose or fall.

    Product
    MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2019·2019-01-23

    Conformis iTotal Hip Replacement System Reamed with Incorrect Interference Fit

    Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.

    Product
    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0727-2019·2019-01-23

    Volcano Visions PV .035 Digital IVUS Catheter Recalled for Guidewire Issue

    Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.

    Product
    Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0729-2019·2019-01-23

    Waldemar Link Recalls BiMobile UHMWPE Liners Due to Labeling Errors

    Waldemar Link is recalling 31 BiMobile UHMWPE Liners because internal labels may contain incorrect part numbers, risking errors in patient records.

    Product
    BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0725-2019·2019-01-23

    Canadian Hospital Specialties Recalls Pediatric Polyurethane Feeding Tubes Due to Labeling Error

    Canadian Hospital Specialties is recalling 750 pediatric polyurethane feeding tubes because they may be packaged with a 5FR tube instead of the labeled 6.5FR size.

    Product
    MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0728-2019·2019-01-23

    Waldemar Link BiMobile UHMWPE Liner Recalled for Incorrect Internal Labeling

    Waldemar Link is recalling 30 BiMobile UHMWPE Liners because internal labeling may contain incorrect part numbers, risking errors in patient records.

    Product
    BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0723-2019·2019-01-23

    Arrow Pediatric Central Venous Catheter Recalled for Incorrect Labeling

    Arrow International Inc. is recalling specific lots of pediatric central venous catheters because the lidstock labels list incorrect priming volumes and flow rates.

    Product
    Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2019·2019-01-23

    Volcano Visions PV .035 Digital IVUS Catheter Recall for Guidewire Issue

    Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.

    Product
    Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0746-2019·2019-01-23

    DeRoyal Enteral Safe Feed Tube Recall Due to Incorrect Sizing

    DeRoyal Industries is recalling 200 Enteral Safe Feed Tubes labeled as 6.5 FR but containing 5 FR tubes. The recall covers units distributed to Texas and Utah.

    Product
    DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0747-2019·2019-01-23

    Ethicon Recalls PERMA-HAND Silk Sutures Due to Labeling Mismatch

    Ethicon is recalling 840 units of PERMA-HAND Silk Sutures because the product inside the packaging does not match the size or type indicated on the label.

    Product
    PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-0697-2019·2019-01-16

    Swissray Medical Recalls ddRCombi Plus FP X-ray Systems Due to Lifting Column Defect

    Swissray Medical AG is recalling three ddRCombi Plus FP X-ray systems because a lifting column component may break, causing the arm to drop and potentially seriously injure patients or users.

    Product
    ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0692-2019·2019-01-16

    Agfa-Gevaert Recalls DX-D 600 Direct Radiography Systems Due to Movement Defect

    Agfa-Gevaert is recalling 10 DX-D 600 Direct Radiography Systems because the Overhead Tube Crane may continue moving after the control button is released.

    Product
    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2019·2019-01-16

    Philips Ingenia MRI Systems Recalled for Table Movement Safety Issue

    Philips is recalling Ingenia Elition S and X MRI systems because pressing the Stop Table button during automatic movement may cause the table to restart unexpectedly.

    Product
    Ingenia Elition S, Ingenia Elition X
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0695-2019·2019-01-16

    Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer

    Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2019·2019-01-16

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Collimator Locking Hazard

    GE Healthcare is recalling 339 Discover VH/Millennium VG Nuclear Medicine Imaging Systems worldwide because a collimator locking handle may fail to engage, posing a potential hazard to patients during scans.

    Product
    Discover VH/Millennium VG Nuclear Medicine Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2019·2019-01-16

    Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer

    Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the actual screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0698-2019·2019-01-16

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to a risk of detachment of the Compact Gantry Rolling Floor.

    Product
    Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2019·2019-01-16

    Elekta Unity MRI Speakers May Become Dislodged and Enter Bore

    Elekta Limited is recalling two Elekta Unity MRI systems because speakers can become dislodged and be pulled into the bore in rare circumstances.

    Product
    Elekta Unity
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0702-2019·2019-01-16

    Cardinal Health Recalls Presource Kit Total Joint Pack Due to Sterility Concerns

    Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.

    Product
    Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0693-2019·2019-01-16

    GE Healthcare Recalls MRI Systems Due to Possible Incorrect Software Version

    GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.

    Product
    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled for Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the physical screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the…
    Category
    Medical Device
    Distribution
    0 states