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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

17376–17400 of 40248

  • HighFDA (Devices)·Z-2033-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress

    Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2020·2020-05-27

    Frames Direct Prescription Spectacle Lenses Recalled for Shatter Resistance Failure

    Frames Direct is recalling 87 pairs of prescription spectacle lenses that failed shatter resistance safety specifications, posing a risk of cracked or broken lenses.

    Product
    Frames Direct Prescription Spectacle Lenses included in the frame brands
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2090-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2016-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2020·2020-05-27

    Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue

    The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.

    Product
    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry

    Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2020·2020-05-27

    Baylis Medical Recalls NRG RF Transseptal Kits Due to Packaging Defect

    Baylis Medical is recalling NRG RF Transseptal Kits because sterile packaging may be compromised during shipping, posing a remote risk of infection.

    Product
    NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2095-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may detach from its post inside the packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2043-2020·2020-05-27

    Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2061-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2020·2020-05-27

    BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes

    Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.

    Product
    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2020·2020-05-27

    NelDerm Hydrogel Dressing Recalled for Foreign Material in Packaging

    Nelson Innovations is recalling NelDerm Hydrogel Dressings due to foreign material near the adhesive edge within the pouch packaging.

    Product
    NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2040-2020·2020-05-27

    Medline Recalls Surgical Kits Due to Potential Loss of Sterility

    Medline is recalling 92,902 custom surgical convenience kits because packaging seal voids may have caused a loss of sterility on the outside of the foil pouch.

    Product
    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2020·2020-05-27

    Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse

    Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.

    Product
    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2020·2020-05-27

    BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

    Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.

    Product
    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2020·2020-05-27

    Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns

    Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.

    Product
    Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2020·2020-05-27

    Medline Recalls Silicone Foley Catheters Due to Loose Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2066-2020·2020-05-27

    Baxter Recalls Prismaflex Control Units Lacking FDA Clearance

    Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.

    Product
    Prismaflex Control Unit
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2098-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
    Category
    Medical Device
    Distribution
    30 states