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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35276–35300 of 40325

  • ModerateFDA (Devices)·Z-2087-2014·2014-07-30

    Synthes Orthopedic Guide Blocks Recalled for Incorrect Labeling

    Synthes, Inc. is recalling 180 Guide Blocks for the Volar Distal Radius Plate System due to incorrect package labeling. The physical parts are correctly marked, but the packaging may identify the wrong side.

    Product
    Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2014·2014-07-30

    Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating

    Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.

    Product
    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2106-2014·2014-07-30

    Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate

    Terumo CVS is recalling 125 CPB Catheter Kits because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2014·2014-07-30

    Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

    Teleflex Medical is recalling 11,679 Hudson RCI Breathing Circuits because the temperature probe does not properly connect to the temperature port.

    Product
    Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2097-2014·2014-07-30

    Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate

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

    Product
    Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2014·2014-07-30

    Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect

    Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.

    Product
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2105-2014·2014-07-30

    Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2102-2014·2014-07-30

    Terumo Dual-stage Venous Return Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of venous return cannulae used in heart surgery due to loose fiber particulate found during inspection.

    Product
    Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2104-2014·2014-07-30

    Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2014·2014-07-30

    ITC-Nexus Dx Recalls Hemochron Jr. APTT Cuvettes Due to Test Errors

    ITC-Nexus Dx is recalling Hemochron Jr. APTT cuvettes because they may produce erroneously elevated test results or out-of-range high error codes in non-heparinized blood samples.

    Product
    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2083-2014·2014-07-30

    DePuy Orthopaedics Recalls RECLAIM Distal Tapered Surgical Instruments

    DePuy Orthopaedics is recalling RECLAIM Distal Tapered surgical instruments because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-2095-2014·2014-07-30

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate

    Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2093-2014·2014-07-30

    Salter Labs Recalls Oxygen Masks Due to Incorrect Labeling

    Salter Labs is recalling 584 units of Model No. 8120-7 oxygen masks because the insert label incorrectly identifies the device as a non-rebreather instead of a partial rebreather.

    Product
    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2014·2014-07-30

    Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2113-2014·2014-07-30

    Biogenex InSite HER-2 Detection Kit Recalled for Lack of FDA Approval

    Biogenex Laboratories is recalling four InSite HER-2 Detection Kits distributed in Brazil and Ecuador without FDA 510(k) approval.

    Product
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2103-2014·2014-07-30

    Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.

    Product
    Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2090-2014·2014-07-30

    Zoll Circulation Recalls AutoPulse Accessories Due to Japanese Label Typo

    Zoll Circulation is recalling 161 NiMH batteries and 40 LifeBand packs distributed in Japan due to a typographical error on the Japanese legal label.

    Product
    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2046-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2058-2014·2014-07-23

    Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.

    Product
    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2014·2014-07-23

    Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks

    Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.

    Product
    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP Coagulation Instruments

    Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP (Base), automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Monitor Mounts

    Stryker Communications is recalling SHAPE Arm monitor mounts because the mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2014·2014-07-23

    Stryker SHAPE Arm Recall for Potential Monitor Mount Detachment

    Stryker Communications is recalling 953 SHAPE Arm components because the monitor mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2014·2014-07-23

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Packaging Defects

    Baxter Healthcare is recalling 585,360 units of MiniCap with Povidone-Iodine Solution due to inadequate iodine and packaging defects.

    Product
    Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 300 CTS Coagulation Instruments

    Instrumentation Laboratory Co. is recalling ACL TOP 300 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 300 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide