The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

18001–18025 of 88183

  • HighFDA (Devices)·Z-2078-2023·2023-07-12

    PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.

    Product
    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2023·2023-07-12

    Giraffe OmniBed neonatal incubator recall due to incorrect secondary latch installation

    GE HealthCare is recalling Giraffe OmniBed neonatal incubators with potentially incorrect secondary latches on bedside panels. An incorrect latch type may have been installed on northeast and/or northwest panels of affected units.

    Product
    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2071-2023·2023-07-12

    SurgiMend collagen matrices recalled for endotoxin test result quality issues

    TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.

    Product
    SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0894-2023·2023-07-12

    Tizanidine tablets recalled nationwide for failed stability specifications

    Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2095-2023·2023-07-12

    Teleflex Pilling O'Reilly Esophageal Retractor Recalled for Incomplete Cleaning Instructions

    TELEFLEX LLC recalled the Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A) due to incomplete pre-cleaning instructions in the product's Instructions for Use. The recall affects 365 units distributed nationwide and internationally.

    Product
    Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2092-2023·2023-07-12

    NexGen Tibial Plate Recalled for Incorrect Outer Packaging Label

    Zimmer, Inc. is recalling NexGen Precoat Stemmed Tibial Plate Size 5 devices due to incorrect outer packaging labeling. Affected units were distributed internationally in India.

    Product
    NexGen Precoat Stemmed Tibial Plate Size 5
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2084-2023·2023-07-12

    Collagen matrix recalled for endotoxin testing methodology issues

    TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses have been reported.

    Product
    Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0892-2023·2023-07-12

    Prescription Drug Tizanidine Tablets Recalled for Failed Dissolution Specifications

    Amerisource Health Services LLC recalls approximately 4,971 cartons of Tizanidine Tablets due to failed dissolution specifications. Tablets that do not dissolve properly may not provide intended therapeutic benefit.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2023·2023-07-12

    Teleflex Surgical Retractor Recalled for Incomplete Pre-Cleaning Instructions

    Teleflex LLC is recalling 170 units of the Pilling Lowsley Prostatic Retractor due to incomplete pre-cleaning instructions in the user manual. Incomplete instructions may prevent proper sterilization of the surgical instrument.

    Product
    Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2093-2023·2023-07-12

    COVID-19 Test Strips Recalled for Lot Number Label Discrepancy

    NeuMoDx SARS-CoV-2 test strips from lot 123909 have conflicting lot numbers between the package label and barcode label that the instrument reads.

    Product
    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2023·2023-07-12

    KLS Martin Battery Packs Recalled for Switched Expiration Date Labels

    Pro-Dex Inc recalls KLS Martin Battery Packs used in surgical screwdrivers due to manufacturing and expiration dates being reversed on sterile pouch labels, causing batteries to appear prematurely expired.

    Product
    KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1876-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall — FDA Class I

    TELEFLEX endotracheal tubes (Murphy design) may have a disconnected 15mm connector. Approximately 12,382 affected units were distributed nationwide. Healthcare facilities should inspect tubes before use.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1893-2023·2023-07-05

    Teleflex Endotracheal Tubes Recalled Due to Connector Disconnection Risk

    Teleflex is recalling 18,620 endotracheal tubes due to reported disconnection of 15mm connectors. The tubes are used for oral and nasal intubation and were distributed nationwide.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2000-2023·2023-07-05

    MEGADYNE MEGA SOFT Return Electrode Recalled for Burns During Surgical Procedures

    Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns that occurred during electrosurgical procedures.

    Product
    MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1994-2023·2023-07-05

    MEGADYNE MEGA 2000 Patient Return Electrode Recalled Due to Patient Burns

    The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode due to reports of patient burns during electrosurgical procedures. All units distributed nationwide are affected.

    Product
    MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1841-2023·2023-07-05

    Slick Set Uncuffed Endotracheal Tube Connector Disconnection Recall

    Teleflex LLC is recalling approximately 10,650 units of Slick Set Uncuffed Endotracheal Tubes due to reports of 15mm connector disconnection from the tube.

    Product
    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1874-2023·2023-07-05

    Endotracheal Tube Recall Due to 15mm Connector Disconnection

    TELEFLEX is recalling endotracheal tubes due to reports of 15mm connector disconnection. Approximately 25,160 units were distributed nationwide.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1947-2023·2023-07-05

    Preformed AGT Endotracheal Tubes Recalled Due to Connector Disconnection

    Teleflex is recalling 25,520 Preformed AGT endotracheal tubes due to reports of 15mm connector disconnection. This is an FDA Class I recall affecting units distributed nationwide.

    Product
    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1927-2023·2023-07-05

    Endotracheal Tubes Recalled for Connector Disconnection Risk

    Teleflex LLC is recalling 2,860 endotracheal tubes due to reports of 15mm connector disconnection. Affected tubes were distributed nationwide including Puerto Rico.

    Product
    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1898-2023·2023-07-05

    RUSCHELIT Safety Clear Tracheal Tube 15mm Connector Disconnection Recall

    TELEFLEX is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reported disconnection of the 15mm connector, affecting approximately 37,076 units distributed nationwide.

    Product
    RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1882-2023·2023-07-05

    TELEFLEX Endotracheal Tubes Recalled Due to Connector Disconnection Risk

    TELEFLEX is recalling 760 endotracheal tubes due to reports of 15mm connector disconnection. This medical device failure could compromise airway management during critical care.

    Product
    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1890-2023·2023-07-05

    Teleflex endotracheal tubes recalled for connector disconnection defect

    Teleflex LLC is recalling 170,179 endotracheal tubes nationwide due to reports of 15mm connector disconnection. The tubes are used for airway management in medical facilities.

    Product
    Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1999-2023·2023-07-05

    MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode Recalled for Patient Burns

    Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical procedures.

    Product
    MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1828-2023·2023-07-05

    Teleflex Slick Set endotracheal tubes recalled for connector disconnection

    Teleflex Slick Set endotracheal tubes (REF 170055) are being recalled by the FDA following reports of disconnection of the 15mm connector. This Class I recall affects approximately 3,530 units distributed nationwide.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1866-2023·2023-07-05

    Endotracheal Tube Connector Disconnection Recall for Teleflex Preformed AGT Tubes

    Teleflex is recalling 3,309 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This defect may compromise airway management during medical use.

    Product
    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055
    Category
    Medical Device
    Distribution
    Distributed nationwide