Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 17, 2022 | #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W... | Packaging error. | Class II | Baxter Healthcare Corporation |
| May 17, 2022 | 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide... | Scapula Marking Guide (anatomically Shaped) was incorrectly designed. | Class II | Medical Modeling, Inc. |
| May 16, 2022 | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | Due to a potential failed sterilization process. | Class II | Volcano Corp |
| May 16, 2022 | Drager SafeStar 55, Catalog No. MP01790 | Possible occlusion of filters due to manufacturing error. | Class I | Draeger Medical, Inc. |
| May 13, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 | There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for ... | Class II | NeuMoDx Molecular Inc |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , R... | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Volcano Corp |
| May 13, 2022 | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbe... | The affected staplers have the potential for the staple guide to not be securely attached to the ... | Class II | Covidien, LP |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx ... | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Volcano Corp |
| May 13, 2022 | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MIC... | The outer package is mislabeled and the package contains a different IOL strength. | Class II | Rayner Intraocular Lenses Ltd |
| May 11, 2022 | Medline Pill Splitters; 1 each/box; 144 boxes/carton | Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 11, 2022 | Alcon Clareon IOL with AutonoMe Delivery System | Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product... | Class II | Alcon Laboratories Ireland, Ltd |
| May 10, 2022 | CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-00... | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component fa... | Class II | GE Healthcare, LLC |
| May 10, 2022 | VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS | Potential for incomplete seals. | Class II | Stradis Healthcare |
| May 9, 2022 | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be us... | Due to a manufacturing issue that may result in filter leakage. | Class II | Dynasthetics LLC |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.3836... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 6, 2022 | VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600... | Paint particles may detach and fall in the operating field. In the worst case scenario, infection... | Class II | Getinge Usa Sales Inc |
| May 6, 2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III | Microbiologics Inc |
| May 5, 2022 | DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial ... | Class II | Encore Medical, LP |
| May 5, 2022 | Arrow Three-Lumen CVC | Gravity flow rates on the affected product lidstock are incorrect. | Class II | ARROW INTERNATIONAL Inc. |
| May 5, 2022 | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MW... | The loading cartridges included with these devices may contain a small, unintended, stainless-ste... | Class II | Cook Incorporated |
| May 5, 2022 | HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... | Class I | Medtronic Inc |
| May 5, 2022 | Tornado Embolization Microcoil, RPN ... | The loading cartridges included with these devices may contain a small, unintended, stainless-ste... | Class II | Cook Incorporated |
| May 5, 2022 | Nester Embolization Microcoil RPN GPN ... | The loading cartridges included with these devices may contain a small, unintended, stainless-ste... | Class II | Cook Incorporated |
| May 4, 2022 | PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK | One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. | Class II | MicroPort Orthopedics Inc. |
| May 4, 2022 | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temper... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 3, 2022 | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSe... | cybersecurity vulnerability | Class II | Illumina, Inc. |
| May 3, 2022 | regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003 | Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. | Class II | ROi CPS LLC |
| May 3, 2022 | illumina Model NextSeq 550 Dx REF 20005715 | cybersecurity vulnerability | Class II | Illumina, Inc. |
| May 3, 2022 | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II | Medtronic Xomed, Inc. |
| May 3, 2022 | Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit | The device is unable to meet sterilization requirements when sterilized per instructions in an Ae... | Class II | Tornier, Inc |
| May 3, 2022 | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. ... | Potential for the tip of the electrode to detach during use. | Class II | ROi CPS LLC |
| May 3, 2022 | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II | Medtronic Xomed, Inc. |
| May 3, 2022 | STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF... | The endoscope may experience a loss of image when activating monopolar electrocautery, due a manu... | Class II | Karl Storz Endoscopy |
| May 3, 2022 | System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model ... | CT operation may be restricted by an interlock which is a result of an system error and the CT sy... | Class II | Canon Medical System, USA, INC. |
| May 2, 2022 | Flow-e Anesthesia System : Intended for use in administering anesthesia while... | Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... | Class I | Getinge Usa Sales Inc |
| May 2, 2022 | Flow-c Anesthesia System : intended for use in administering anesthesia whil... | Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... | Class I | Getinge Usa Sales Inc |
| May 2, 2022 | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID ... | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| May 2, 2022 | Clean Catch Urine Kit NS 178489, AHMU58A | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J ... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 29, 2022 | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, 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.