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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31451–31475 of 40325

  • ModerateFDA (Devices)·Z-0367-2016·2015-12-09

    Merz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling Prolaryn Injectable Implant 1.0 cc Gel because the expiration date on the label is incorrect.

    Product
    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0343-2016·2015-12-09

    Ormco Recalls Copper NiTi Preformed Archwires Due to Incorrect Labeling

    Ormco is recalling Copper NiTi Preformed Archwires because the transformation temperature listed on the label is incorrect.

    Product
    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2016·2015-12-09

    Procedure Products Recalls Ultra Modified Seldinger Needles Due to Insertion Difficulty

    Procedure Products, Inc. is recalling 1,100 non-sterile Seldinger needles because a medical professional reported difficulty inserting a guide wire.

    Product
    U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0368-2016·2015-12-09

    Merz Recalls Prolaryn Plus Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling Prolaryn Plus Injectable Implants because the expiration date on the labels is incorrect. The recall covers 9,439 units distributed in the US and South Africa.

    Product
    PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0271-2016·2015-12-02

    Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation

    Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.

    Product
    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0337-2016·2015-12-02

    NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error

    NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0327-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 365 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2016·2015-12-02

    Siemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.

    Product
    ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0336-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0324-2016·2015-12-02

    Pega Medical Recalls SCFE Driver Instruments Due to Threaded Shaft Breakage

    Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke during use.

    Product
    SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0320-2016·2015-12-02

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 2,134 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0338-2016·2015-12-02

    Masimo Recalls Rainbow Reusable Sensors Due to Inaccurate Readings

    Masimo is recalling Rainbow Reusable Sensors because incompatible configurations may cause no readings or inaccurate SpCO and SpMet results.

    Product
    rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2016·2015-12-02

    Siemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results

    Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.

    Product
    Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0332-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 150 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2016·2015-12-02

    Siemens Syngo Imaging Software Recall for Version VB36D_HF02

    Siemens Medical Solutions is recalling three units of Syngo Imaging software to provide supplementary information regarding the release of Version VB36D_HF02.

    Product
    Syngo Imaging VB36D_HF02. Radiological image processing system.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0321-2016·2015-12-02

    Medtronic Sofamor Danek Recalls Midas Rex Legend Wire Pass Tools

    Medtronic Sofamor Danek is recalling 9 Midas Rex Legend wire pass tools because the wire pass hole is missing. The tools were distributed in California, New York, Texas, and Belgium.

    Product
    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0329-2016·2015-12-02

    Palindrome Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 160 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2016·2015-12-02

    Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents

    Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.

    Product
    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2016·2015-12-02

    BD CD64 APC-R700 Reagent Recalled Due to CD4 Antibody Contamination

    Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.

    Product
    BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0325-2016·2015-12-02

    Philips MRI Systems Recalled for Reversed Image Order in MobiView Software

    Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.

    Product
    Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide