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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35126–35150 of 40449

  • HighFDA (Devices)·Z-2563-2014·2014-09-10

    Roche cobas IT 1000 Recalled for Potential Patient ID Mismatch

    Roche Diagnostics is recalling 148 cobas IT 1000 devices because they may assign test results to the wrong patient ID if specific system messages are received.

    Product
    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisionals Recalled for Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings after receiving a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2560-2014·2014-09-10

    OrthoPediatrics ACL Sleeve Installation Tool Recalled for Weld Fractures

    OrthoPediatrics Corp is recalling 56 ACL Sleeve Installation Tools due to weld fractures. The tools are used in pediatric and small stature adult ACL reconstruction systems.

    Product
    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2014·2014-09-10

    Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors

    Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.

    Product
    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2573-2014·2014-09-10

    Pioneer Surgical Technology Recalls Streamline CT Set Screws

    Pioneer Surgical Technology is recalling 11 sets of Streamline CT Cervico-Thoracic System set screws because some thread profiles were not within specifications.

    Product
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2566-2014·2014-09-10

    Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up

    Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.

    Product
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2591-2014·2014-09-10

    Mentor Saline Breast Implant Sizer Recalled for Volume Labeling Error

    Mentor Texas, LP. is recalling 34 units of saline breast implant sizers because the device labeling states 330cc while the actual device volume is 380cc.

    Product
    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2582-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings due to a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2571-2014·2014-09-10

    Siemens Recalls V5Ms Transesophageal Ultrasound Transducers Due to Material Deterioration

    Siemens is recalling 321 V5Ms transesophageal ultrasound transducers because the material covering the articulating section has deteriorated.

    Product
    V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2592-2014·2014-09-10

    MedComp Recalls Split Cath III Trays Due to Incorrect Length Labeling

    Medical Components, Inc. is recalling 110 Split Cath III Trays because they were incorrectly labeled as 32CM instead of 28CM.

    Product
    Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2014·2014-09-10

    Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

    Product
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2568-2014·2014-09-10

    Datascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error

    Datascope Corporation is recalling Linear 7.5 FR 40cc Intra-Aortic Balloon Catheters due to a duplicate serial number label detected during label reconciliation.

    Product
    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2243-2014·2014-09-03

    Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation

    Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.

    Product
    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign…
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-2539-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2541-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders

    Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2536-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2540-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2537-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2538-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2553-2014·2014-09-03

    Siemens Dimension EXL Chemistry System Recalled for Hinge Injury Risk

    Siemens is recalling 2,757 Dimension EXL Integrated Chemistry Systems because a reagent lid hinge may shift during maintenance, posing a risk of physical injury to operators.

    Product
    Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2014·2014-09-03

    Curbell Medical Recalls CareSense Bed and Chair Monitors

    Curbell Medical is recalling CareSense Wireless Advanced LCD Bed and Chair Monitors because a circuit board modification disabled the alarm function.

    Product
    CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2014·2014-09-03

    Cordis EMPIRA NC RX PTCA Dilatation Catheter Recalled for Balloon Defect

    Cordis Corporation is recalling 250,000 EMPIRA NC RX PTCA Dilatation Catheters because the balloon cover may be difficult to remove, potentially causing the balloon to burst or the shaft to separate during use.

    Product
    Cordis EMPIRA NC RX PTCA Dilatation Catheter
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2544-2014·2014-09-03

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Programming Error

    Medtronic is recalling MiniMed Paradigm insulin pumps because users may have accidentally programmed them to deliver the maximum bolus amount.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2014·2014-09-03

    Zimmer Recalls Moore & Thompson Hip Stems Due to Packaging Failures

    Zimmer, Inc. is recalling Moore & Thompson Hip Stems because packaging design verification tests failed, resulting in compromised seal integrity or breached trays.

    Product
    Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP…
    Category
    Medical Device
    Distribution
    0 states