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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31576–31600 of 40449

  • SevereFDA (Devices)·Z-0296-2016·2015-11-25

    Fresenius Modified Mixer Motor Recalled Due to Fire Risk

    Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.

    Product
    Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2016·2015-11-25

    Brainlab IGS System Recalled for Inaccurate Patient Anatomy Registration

    Brainlab AG is recalling 12 Image Guided Surgery systems in the US and Australia because data sets were not accurately registered to patient anatomy.

    Product
    BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0280-2016·2015-11-25

    Cyberonics Vagus Nerve Stimulator Recall for Sensing Delays

    Cyberonics is recalling 27 Model 106 Vagus Nerve Stimulator generators due to delays in heartbeat detection and potential decreased battery longevity.

    Product
    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0310-2016·2015-11-25

    Ameditech Recalls Benzodiazepine Drug Abuse Tests Due to Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2016·2015-11-25

    Civco Needle Guide Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2016·2015-11-25

    Ameditech Recalls DrugCheck Waived 12 Panel Cup Tests

    Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.

    Product
    DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2016·2015-11-25

    Ameditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity

    Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and Australia.

    Product
    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2016·2015-11-25

    Civco PercuNav Tracking Bracket Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.

    Product
    CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2016·2015-11-25

    Synthes Sternal ZIPFIX Application Instrument Recall for Screw Failure Risk

    Synthes is recalling 267 previously repaired Sternal ZIPFIX Application Instruments because the screws may break or loosen.

    Product
    Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0313-2016·2015-11-25

    Ameditech Recalls Micro Screen 6 Panel Drug Abuse Test Cups

    Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.

    Product
    Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0273-2016·2015-11-25

    Philips ECG Sync Cables Recalled for Electrical Interference Risk

    Philips is recalling ECG sync cables used with HeartStart monitors because electrical interference can cause misinterpretation of heart signals or interrupt pacing.

    Product
    ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2016·2015-11-25

    Stryker Recalls PCA Acetabular Inserts Due to Regulatory Omission

    Stryker Howmedica Osteonics Corp. is recalling six PCA 10 Degree Hooded Acetabular Inserts because the 22 mm size was inadvertently omitted from the FDA 510(k) clearance.

    Product
    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0272-2016·2015-11-25

    Precision Medical Recalls Easy Dial Oxygen Regulators Due to Label Error

    Precision Medical is recalling 315 Easy Dial Oxygen Regulators because the settings label may be off by one position, causing incorrect oxygen flow.

    Product
    Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0292-2016·2015-11-25

    Leonhard Lang Recalls ECG Electrodes Due to Signal Transmission Failure

    Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.

    Product
    ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 58051  Skintact W-60 50547  Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0290-2016·2015-11-25

    Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides

    Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2016·2015-11-25

    Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2016·2015-11-25

    Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2016·2015-11-25

    Roche Bulk Loader Module Recalled for Sample Contamination Risk

    Roche Diagnostics is recalling Bulk Loader Modules for cobas p 512/612 instruments because sample tubes may open during transport, causing system and sample contamination.

    Product
    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0293-2016·2015-11-25

    TZ Medical Neptune Plus Hemostasis Pad Recall for Labeling Mismatch

    TZ Medical Inc. is recalling Neptune Plus hemostasis pads because the instructions for use do not match the original FDA submission.

    Product
    Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0275-2016·2015-11-25

    Medacta Recalls GMK Hinge Knee Prosthesis Due to Incorrect Screws

    Medacta USA is recalling 4 units of GMK Hinge knee prostheses because they contain 5 mm screws instead of the required 10 mm screws.

    Product
    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0312-2016·2015-11-25

    Ameditech Recalls Immutest Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling specific Immutest drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and in Australia.

    Product
    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2016·2015-11-25

    Ameditech Recalls 1 Step 12 Panel Cup Drug Tests

    Ameditech is recalling 787 kits of 1 Step 12 Panel Cup drug tests due to reduced reactivity. The products were distributed in the US and Australia.

    Product
    1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0279-2016·2015-11-25

    Astora Recalls MiniArc Pro Sling System Due to Labeling Mismatch

    Astora is recalling 52 units of the MiniArc Pro Single incision Sling System because the lot number on the outer carton did not match the labels inside the box.

    Product
    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0311-2016·2015-11-25

    Ameditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity

    Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.

    Product
    iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0278-2016·2015-11-25

    Ethicon Harmonic ACE+ 7 Laparoscopic Shears Recalled for Packaging Defect

    Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.

    Product
    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide