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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30476–30500 of 40325

  • HighFDA (Devices)·Z-1326-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, which may affect the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2016·2016-04-13

    GE Medical Systems Recalls SIGNA Pioneer MR Systems Due to Ferrous Material Risk

    GE Medical Systems is recalling 16 SIGNA Pioneer MR systems because ferrous material in the Table Control Box could cause unexpected attraction to the magnetic field during servicing, posing a risk of serious injury to personnel.

    Product
    SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Direct Amplification Discs for Diagnostic Errors

    Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2016·2016-04-13

    Laserex Systems Recalls Ellex Medical Fixed Eye Safety Filters

    Laserex Systems Inc. is recalling 74 Ellex Medical Fixed Eye Safety Filters due to a design error in the optic adaptor that may compromise eye protection.

    Product
    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1328-2016·2016-04-13

    MicroAire PAL-R4011XL Cannula Recalled Due to Breakage During Surgery

    MicroAire is recalling PAL-R4011XL cannulas because three reports indicated the devices bent or broke during surgical procedures.

    Product
    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 8 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1331-2016·2016-04-13

    Applied Medical Resources Recalls Epix Universal Clip Applier Kits

    Applied Medical Resources is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2016·2016-04-13

    Cardinal Health Recalls Gomco Style Circumcision Clamp Trays Due to Labeling Error

    Cardinal Health is recalling Gomco Style Circumcision Clamp Trays because two lots were labeled as containing 1.1cm clamps but actually contained 1.3cm clamps.

    Product
    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2016·2016-04-13

    Siemens PACS Software Recall for Incorrect Distance Measurements

    Siemens Medical Solutions is recalling 49 PACS systems because they may display incorrect distance measurements when used with certain modalities and syngo Imaging.

    Product
    A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2016·2016-04-13

    GE Cabinet X-ray Systems Recalled for Non-Compliance with FDA Standards

    GE Inspection Technologies is recalling 55 cabinet x-ray systems used for industrial quality control because they may not fully comply with FDA performance standards.

    Product
    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1340-2016·2016-04-13

    Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

    Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product information on the box differed by sides, showing conflicting part and lot numbers.

    Product
    Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1332-2016·2016-04-13

    Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Defect

    Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1329-2016·2016-04-13

    Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Mechanism Defect

    Applied Medical Resources Corp is recalling CA500 Epix Universal Clip Appliers due to a potential loading mechanism nonconformance. The recall affects 1,771 units distributed in the U.S. and internationally.

    Product
    CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1341-2016·2016-04-13

    Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

    Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product box displayed conflicting part and lot numbers on different sides.

    Product
    Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1330-2016·2016-04-13

    Applied Medical Resources Recalls Epix Universal Clip Applier Kits

    Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1333-2016·2016-04-13

    Karl Storz Endoscope Cleaning Brush Recalled for Fit Issues

    Karl Storz is recalling 16,908 endoscope cleaning brushes because they may not fit into the endoscope channel, preventing proper cleaning.

    Product
    ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1314-2016·2016-04-13

    Northeast Laboratory Services Recalls GBS Medium Tubes for Missing 510(k) Clearance

    Northeast Laboratory Services is recalling 11,720 units of GBS Medium tubes because they were marketed without FDA 510(k) clearance.

    Product
    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2016·2016-04-13

    Northeast Laboratory Services Recalls GBS Medium for Missing 510(k) Clearance

    Northeast Laboratory Services is recalling 9,300 units of GBS Medium because the product was marketed without FDA 510(k) clearance.

    Product
    NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1325-2016·2016-04-13

    Fresenius 2008 Series Hemodialysis Machines Recalled for False Blood Leak Alarms

    Fresenius Medical Care is recalling 2008 Series hemodialysis machines because they may trigger false blood leak alarms when treating patients with Vitamin B-12.

    Product
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1321-2016·2016-04-13

    ArthroCare Recalls TOPAZ MicroDebrider Devices Due to Shelf-Life Failure

    ArthroCare Corporation is recalling 26,903 TOPAZ MicroDebrider devices because they failed to meet shelf-life requirements at their expiration dates.

    Product
    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1319-2016·2016-04-13

    Richard-Allan Scientific Recalls Type 3 Paraffin Due to Mislabeling

    Richard-Allan Scientific is recalling Type 3 Paraffin because customers found Type 6 Paraffin inside the boxes. The product is used for histology tissue processing.

    Product
    Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and…
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1309-2016·2016-04-06

    ViewRay MRIdian Radiation Therapy System Software Recall

    ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.

    Product
    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1305-2016·2016-04-06

    Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2016·2016-04-06

    PMBS S.C.O.R.E.S. Unit Recall Due to Potential Sterility Compromise

    PMBS, LLC is recalling 58 S.C.O.R.E.S. Units because water retention in filters may compromise sterility. The units were distributed to seven states.

    Product
    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
    Category
    Medical Device
    Distribution
    8 states