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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30051–30075 of 40449

  • HighFDA (Devices)·Z-1878-2016·2016-06-08

    Natus Medical Recalls Replacement HEPA Filters for Sterile-Driers

    Natus Medical is recalling 21 replacement HEPA filters for Sterile-Driers because improperly cured sealant may emit toxic gas or drip, contaminating the device.

    Product
    Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1864-2016·2016-06-08

    Fujifilm ED-450XL5 Endoscope Manual Correction for Infection Control

    Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1873-2016·2016-06-08

    Philips Ingenuity Core CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2016·2016-06-08

    Olympus Recalls Duodenoscopes for New Reprocessing Instructions

    Olympus Corporation of the Americas is recalling TJF-160F and TJF-160VF duodenoscopes to provide new reprocessing instructions and a cleaning brush.

    Product
    EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1872-2016·2016-06-08

    Philips Brilliance 64 CT Systems Recalled for Software Mapping Error

    Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.

    Product
    Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1901-2016·2016-06-08

    Exactech Recalls Two Novation Ceramic Hip Acetabular Cups

    Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1876-2016·2016-06-08

    Leica Novocastr Antibody Recalled for Stability Issues

    Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1904-2016·2016-06-08

    Exactech Recalls One Novation Femoral Stem Device for Premature Packaging

    Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1865-2016·2016-06-08

    Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference

    Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.

    Product
    The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1840-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,128 COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2016·2016-06-08

    Exactech Recalls Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling nine Novation femoral stems because they were packaged before receiving FDA approval for a site change.

    Product
    Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1903-2016·2016-06-08

    Exactech Recalls One Novation Femoral Stem for Premature Packaging

    Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1843-2016·2016-06-08

    Medscience AllergiEnd Skin Test Applicators Recalled for Lack of Clearance

    Medscience Inc is recalling AllergiEnd ST-9 skin test applicators and trays because they were marketed without FDA clearance.

    Product
    AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1834-2016·2016-06-08

    MicroAire Pneumatic Impactor Recall for Missing Symbol Markings

    MicroAire is recalling 20 Pneumatic Impactor units because they are missing required lock and unlock symbol markings.

    Product
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1874-2016·2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2016·2016-06-08

    Philips Ingenuity CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1900-2016·2016-06-08

    Exactech Recalls Three Ceramic Hip Acetabular Cups Due to Premature Packaging

    Exactech is recalling three Novation Ceramic AHS Cluster-Hole Shells because they were packaged before the required site-change approval was granted.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1839-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1877-2016·2016-06-08

    Leica Microsystems Recalls Unstable CDX2 Antibody Lots

    Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1902-2016·2016-06-08

    Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-1909-2016·2016-06-08

    Affymetrix Recalls CytoScan Dx Assay Kits Due to Missing Warning Statements

    Affymetrix is recalling 507 CytoScan Dx Assay kits because FDA inspectors found that required warning statements were missing from product shipments.

    Product
    CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx…
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-1907-2016·2016-06-08

    B. Braun Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the device.

    Product
    Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1906-2016·2016-06-08

    B. Braun Medical Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling approximately 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the product label.

    Product
    Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1759-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide