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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13926–13950 of 27500

  • HighFDA (Devices)·Z-1642-2020·2020-04-15

    Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1688-2020·2020-04-15

    Abbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias

    Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators because a manufacturing defect may cause biased patient test results outside a specific concentration range.

    Product
    "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2020·2020-04-15

    Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1681-2020·2020-04-15

    Solta Medical Recalls Thermage Face Tips Due to Sparking and Burn Risk

    Solta Medical is recalling Thermage Face Tip 3.0 units because sparking during use could cause skin burns.

    Product
    Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1682-2020·2020-04-15

    Change Healthcare Cardiology ECG Software Recalled for Heart Rate Estimation Errors

    Change Healthcare Canada Company is recalling McKesson and Change Healthcare Cardiology ECG Management software due to potential inaccurate heart rate estimation in Sequential ECG format.

    Product
    McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2020·2020-04-15

    AAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect

    AAP Implantate AG is recalling 7 units of soft tissue retractors because they may not be fully removed during manufacturing, potentially leaving debris in patients.

    Product
    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1643-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1689-2020·2020-04-15

    Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise

    Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, compromising sterility.

    Product
    Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1660-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1647-2020·2020-04-15

    Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1654-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1674-2020·2020-04-15

    Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands

    Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.

    Product
    Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2020·2020-04-15

    Abbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk

    Abbott is recalling ARCHITECT C System Mixers because the blade may separate from the mixer due to screw and nut failure, leading to inadequate mixing of samples and reagents.

    Product
    ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1622-2020·2020-04-08

    Philips V60 Ventilators Recalled for Power Management Board Failure

    Respironics is recalling 23,581 Philips V60 Ventilators because a solder connection failure on the power board may cause the blower to lose power or shut down unexpectedly, potentially leading to hypercarbia or hypoxemia.

    Product
    Philips V60 Ventilators with Power Management PCBA part number 1055906
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-1567-2020·2020-04-08

    LeMaitre Embolectomy Catheter Recall for Deflation Failure and Tip Separation

    LeMaitre Vascular is recalling 5F Plus Over the Wire Embolectomy Catheters due to reports of deflation failure that may lead to tip separation.

    Product
    LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1632-2020·2020-04-08

    Merits E604 Pilot Navigator Stairlift Recalled Due to Pinion Gear Defect

    Merits Health Products is recalling 82 E604 Pilot Navigator Stairlifts because the pinion gear may disengage from the track, allowing the lift to slip or jolt.

    Product
    Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1602-2020·2020-04-08

    Stryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk

    Stryker is recalling 1,415 Berchtold Chromophare Ceiling Mounted Surgical Light Systems because a missing snap ring or spanner nut may cause the light to fall.

    Product
    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2020·2020-04-08

    Physio-Control Recalls LifePAK 500 AEDs Due to Contact Plating Wear

    Physio-Control is recalling 173,459 LifePAK 500 AEDs because mechanical wear on the therapy connector may prevent the device from detecting a patient, potentially delaying treatment.

    Product
    LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2020·2020-04-08

    Smith & Nephew Recalls NAVIO Soft Tissue Protector Due to Binding Risk

    Smith & Nephew is recalling 348 NAVIO Soft Tissue Protectors because the instrument may become stuck to bone pins during surgery.

    Product
    NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2020·2020-04-08

    Karl Storz C-MAC Video Laryngoscope Recall Due to Loose Glass Cover

    Karl Storz is recalling 27,165 C-MAC Video Laryngoscopes because the glass cover at the distal end may become loose during use or reprocessing, potentially delaying procedures or requiring removal from the body.

    Product
    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2020·2020-04-08

    Stryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk

    Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2020·2020-04-08

    Stryker AXS Vecta 74 Aspiration Catheter Recall for Potential Fracture

    Stryker Neurovascular is recalling 1,405 AXS Vecta 74 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2020·2020-04-08

    Maquet Recalls Avalon Elite Vascular Access Kits Due to Needle Mix-up

    Maquet is recalling 255 Avalon Elite Vascular Access Kits because 81 units were assembled with an incorrect arterial needle instead of a multi-purpose needle.

    Product
    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1637-2020·2020-04-08

    Bard WavelinQ 4F EndoAVF System Recalled for Magnetic Deficiency

    Bard Peripheral Vascular is recalling 150 units of the WavelinQ 4F EndoAVF System because magnetic catheters may fail to attract, potentially delaying fistula creation.

    Product
    BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation…
    Category
    Medical Device
    Distribution
    Distributed nationwide