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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36226–36250 of 40449

  • ModerateFDA (Devices)·Z-1258-2014·2014-03-26

    Zimmer Recalls Apollo Knee System Patella Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Apollo Knee System patella components due to discoloration caused by premature oxidation during storage.

    Product
    Apollo" Knee System: APOLLO PATELLA SZ0 28MM R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2014·2014-03-26

    Stryker Recalls 2.5MM Aggressive Sinuscopic Shaver Blades Due to Missing Scale

    Stryker is voluntarily recalling 90 units of 2.5MM Aggressive Sinuscopic Shaver Blades because the etched line guide is missing the required 1cm to 7cm number scale.

    Product
    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1248-2014·2014-03-26

    Zimmer Recalls Natural-Knee Flex System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.

    Product
    Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2014·2014-03-26

    Ortho-Clinical VITROS White Correction Factor Slides Recalled for Labeling Error

    Ortho-Clinical Diagnostics is recalling VITROS White Correction Factor Slides because an incorrect assay value was printed on the carton, which may delay reporting of specific test results.

    Product
    VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2014·2014-03-26

    Zimmer Recalls Natural-Knee Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1233-2014·2014-03-26

    Biomet Recalls Endobon Xenograft Granules Due to Incorrect Batch Labels

    Biomet 3i, LLC is recalling 704 units of Endobon Xenograft Granules 0.5 ML because individual pieces may have incorrect labels with the wrong batch number.

    Product
    ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1176-2014·2014-03-19

    Biosense Webster Recalls PentaRay Nav Catheters Due to Tip Separation Risk

    Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.

    Product
    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1201-2014·2014-03-19

    Mar Cor Purification Reverse Osmosis Systems Recalled for Fire Risk

    Mar Cor Purification is recalling 130 CWP Reverse Osmosis Systems (Models 101, 102, 104, and 106) due to a potential fire hazard from resistive heating in the pump head assembly.

    Product
    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2014·2014-03-19

    GE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss

    GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.

    Product
    GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2014·2014-03-19

    Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure

    Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.

    Product
    G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1199-2014·2014-03-19

    GE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices

    GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2014·2014-03-19

    Maquet Plegiox Cardioplegia Heat Exchanger Recalled for Temperature Discrepancy

    Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.

    Product
    MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1159-2014·2014-03-19

    Smith & Nephew RENASYS-F XL Dressing Kits Recalled for Sealing Defects

    Smith & Nephew is recalling RENASYS-F XL with Soft Port dressing kits due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2014·2014-03-19

    Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure

    Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.

    Product
    REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are sterile, single-use diagnostic tools used for drawing arterial blood.

    Product
    4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1161-2014·2014-03-19

    Smith & Nephew RENASYS-G Gauze Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2014·2014-03-19

    Smith & Nephew RENASYS-AB Abdominal Dressing Kit Recall for Sealing Defects

    Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.

    Product
    Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1185-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The…
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1157-2014·2014-03-19

    Smith & Nephew RENASYS Soft Port Dressing Kits Recalled for Sealing Defects

    Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.

    Product
    Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2014·2014-03-19

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Transmission Bug

    Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.

    Product
    Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.

    Product
    4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line.…
    Category
    Medical Device
    Distribution
    40 states