Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 25, 2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120... | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 25, 2023 | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... | Class I | TELEFLEX LLC |
| May 24, 2023 | RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a labo... | DNAs used during the manufacture of two affected models were accidentally inverted during manufac... | Class II | Cytocell Ltd. |
| May 24, 2023 | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In ... | Complaints that specific samples produced false positive EliA GBM results. A positive signal was ... | Class II | Phadia Ab |
| May 24, 2023 | Power-PRO 2- A powered ambulance cot that consists of a platform, including a... | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... | Class II | Stryker Medical Division of Stryker Corporation |
| May 24, 2023 | NeuMoDx Cartridge-used for extraction, purification, amplification and detect... | Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied d... | Class II | NeuMoDx Molecular Inc |
| May 24, 2023 | RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora... | DNAs used during the manufacture of two affected models were accidentally inverted during manufac... | Class II | Cytocell Ltd. |
| May 23, 2023 | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varni... | Class II | Young Dental Manufacturing I, LLC |
| May 23, 2023 | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 c... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | wDR 2.2 Mobile Digital Diagnostic X-Ray System | There is a software login in issue that may prevent the user from logging in. | Class II | SEDECAL SA |
| May 23, 2023 | SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 ... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes ... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 ... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x2... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 p... | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing a... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2023 | PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm,... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 23, 2023 | PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 1... | Possible out of specification endotoxin test results due to issues with in-process and finished g... | Class II | TEI Biosciences, Inc. |
| May 22, 2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... | Class II | Wilson-Cook Medical Inc. |
| May 22, 2023 | PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS | Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuratio... | Class II | Covidien, LLC |
| May 22, 2023 | PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
| May 22, 2023 | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI... | Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen... | Class II | CareFusion 303, Inc. |
| May 22, 2023 | HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... | Class II | Universal Meditech Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.