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

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

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

39851–39875 of 40480

  • HighFDA (Devices)·Z-2378-2012·2012-09-26

    RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

    RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

    Product
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2402-2012·2012-09-26

    Steris Surgical Table Recalled for Potential Unintended Movement

    Steris Corporation is recalling 11,044 surgical tables because prohibited storage of objects on the base or column can damage the override switch, potentially causing the table to move without operator prompting.

    Product
    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2012·2012-09-26

    Integra HRAIM Head Ring Assembly Recalled for T-Handle Seating Issue

    Integra LifeSciences is recalling HRAIM Head Ring Assemblies because a T-handle screw may prevent the CRW stereotactic system from seating properly.

    Product
    Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2012·2012-09-26

    Roche Amplilink Software Recall Due to Potential Wrong Test Results

    Roche Molecular Systems is recalling Amplilink Software 3.2.3 because it may assign wrong results to orders when used with certain Laboratory Information Systems.

    Product
    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2012·2012-09-26

    Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure

    Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.

    Product
    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2422-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 1,536 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2426-2012·2012-09-26

    Steris Recalls 5085 Surgical Tables Due to Hydraulic Column Damage

    Steris is recalling 379 surgical tables because external impact damage to the hydraulic column can misalign shrouds and impede table movement.

    Product
    STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 152,016 REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2387-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Testing Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.

    Product
    Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2012·2012-09-26

    Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws

    Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.

    Product
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2012·2012-09-26

    Biomet Recalls JuggerKnot In-Guide Punch Due to Knob Unfastening Risk

    Biomet is recalling 62 units of the JuggerKnot 2.9mm In-Guide Punch because the knob may unfasten and slide down the shaft during use.

    Product
    JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 55,632 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2420-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends

    Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2405-2012·2012-09-26

    Elekta Precise Digital Accelerator Recall Due to Loose Drive Gear Joint

    Elekta is recalling 110 Precise Digital Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Precise Digital Accelerator Delivery of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2400-2012·2012-09-26

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals

    Vascular Solutions, Inc. is recalling Guardian II Hemostasis Valves because some pouches are missing a seal, posing a risk of product contamination.

    Product
    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2012·2012-09-26

    Philips Recalls MX 16-slice CT Scanners Due to Bolt Failure Risk

    Philips Medical Systems is recalling 328 MX 16-slice CT Scanner Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2428-2012·2012-09-26

    Integra CRW Precision Arc and HRAIM Head Ring Assembly Recalled

    Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.

    Product
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.

    Product
    Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2012·2012-09-26

    Smith & Nephew Recalls 70 Undersized Modular Hip Neck Components

    Smith & Nephew is recalling 70 modular hip neck components because the taper is undersized due to manufacturing errors.

    Product
    12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 500 CTS Analyzer Recalled for Fibrinogen Errors

    Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 CTS Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2012·2012-09-26

    Varian Linear Accelerators Recalled Due to X-Jaw Carrier Alloy Defect

    Varian Medical Systems is recalling 221 linear accelerators worldwide because incorrect metal alloy in X-jaw carriers may cause cracking and undetected under-dosing.

    Product
    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2380-2012·2012-09-26

    Zoe Medical Recalls Spacelabs Ultraview DM3 Monitors for Power Failure

    Zoe Medical Incorporated is recalling 35 Spacelabs Ultraview DM3 Monitors because they fail to power up, causing equipment alarms.

    Product
    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide