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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

25826–25850 of 27722

  • HighFDA (Devices)·Z-0305-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.

    Product
    VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2014·2013-11-27

    Spacelabs qube Patient Monitor Recalled for Power-On Failure

    Spacelabs Healthcare is recalling 54 qube Compact Patient Monitors because an incorrect microcontroller may prevent the device from powering on.

    Product
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2014·2013-11-27

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables

    Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.

    Product
    Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0364-2014·2013-11-27

    Biomet Recalls Juggerknotless Drill Bits Due to Insertion Difficulty

    Biomet, Inc. is recalling 25 units of Juggerknotless Drill Bits because the design may make it difficult to insert the suture anchor into the bone.

    Product
    Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2014·2013-11-27

    Biomet Spine Recalls Polaris Translation Screws Due to Head Dissociation

    Biomet Spine is recalling 7,092 Polaris Translation Screws because the screw head may separate from the shaft. The recall covers nationwide distribution including Puerto Rico.

    Product
    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2014·2013-11-27

    Aesculap Arcadius XP L Trial Insertion Instrument Recall for Weak Weld

    Aesculap is recalling 30 Arcadius XP L Trial Insertion Instruments because a weak weld may cause the device to disassemble during use.

    Product
    Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2014·2013-11-27

    Trumpf TruSystem Surgical Table Leg Section Recall for Detachment Risk

    Trumpf Medical Systems is recalling 15 TruSystem Surgical Table Leg Section One Part Light components because the coupler point may detach from the frame.

    Product
    TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0375-2014·2013-11-27

    Stryker Spine Recalls XIA Torque Wrenches Due to Fracturing Hex Tips

    Stryker Spine is recalling XIA and Mantis Redux torque wrenches because the hex tips may fracture during final tightening.

    Product
    Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2014·2013-11-27

    Zeiss IOLMaster 500 Recalled for Erroneous Lens Database Value

    Carl Zeiss Meditec is recalling 1,201 IOLMaster 500 devices because an incorrect database value for the AMO Sensar AR40E lens could lead to the implantation of lenses with the wrong diopter.

    Product
    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2014·2013-11-27

    Zeiss IOLMaster Recalled for Incorrect Lens Database Value

    Carl Zeiss Meditec is recalling 4,907 IOLMaster devices because an incorrect lens constant in the internal database could lead to the implantation of intraocular lenses with the wrong power.

    Product
    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0202-2014·2013-11-20

    Synthes 8.5 MM Medullary Reamer Recalled Due to Intraoperative Breakage

    Synthes USA HQ, Inc. is recalling 2,979 units of the 8.5 MM Medullary Reamer because the reamer head can break during surgery, leaving unretrieved fragments of non-implant grade material.

    Product
    Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0280-2014·2013-11-20

    Stryker Recalls Acetabular Pressurizers Due to Cracked Assemblies

    Stryker is recalling 87 boxes of Acetabular Pressurizers because cracked assemblies may release during cement application.

    Product
    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0205-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 71 Plum A+ Infusion Pumps because pressure sensor calibration drift can cause false alarms or missed occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0186-2014·2013-11-20

    Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

    Fresenius Medical Care is recalling 508,029 cases of Combiset Blood Lines for hemodialysis because connections may disconnect if not tightened correctly, leading to blood loss.

    Product
    Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2014·2013-11-20

    Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

    Fresenius Medical Care is recalling 24,202 cases of Combiset Blood Lines with BVM for hemodialysis. The recall addresses a risk of blood loss if connections are not tightened correctly.

    Product
    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Calibration Drift

    Hospira is recalling Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false occlusion alarms or missed occlusions.

    Product
    *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0242-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0184-2014·2013-11-20

    Fresenius Hemodialysis Blood Lines Recalled for Potential Disconnection Risk

    Fresenius Medical Care is recalling 8,528 cases of 2008K@ Home Blood lines due to a risk of disconnection and blood loss if not tightened correctly.

    Product
    2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2014·2013-11-20

    Toshiba Titan 3T MRI System Recalled for SAR Display Error

    Toshiba is recalling 18 Titan 3T MRI systems because they may display lower Specific Absorption Rate (SAR) values than actual when used with specific coils.

    Product
    Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2014·2013-11-20

    Ray Station Radiation Therapy System Recalled for Dose Calculation Error

    Ray Search Laboratories is recalling Ray Station 3.0, 3.5, and 4.0 systems due to a dose calculation error involving Elekta motorized wedges.

    Product
    Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0196-2014·2013-11-20

    Terumo Recalls Sarns Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for venous drainage during cardiopulmonary bypass surgery for dial cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0278-2014·2013-11-20

    Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Loss of Stimulation

    Medtronic is recalling 64,163 RestoreUltra and RestoreSensor neurostimulators worldwide due to a risk of loss of stimulation when switching program groups.

    Product
    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide