Browse Device Recalls
2,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,602 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 2,602 FDA device recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 30, 2020 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to ... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015... | If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirm... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 30, 2020 | Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and mon... | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Pump Module Model 8100 | Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris Pump Module Model 8100, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to trea... | Affected beds may have screws installed that do not meet material tensile strength requirements. ... | Class II | Hill-Rom, Inc. |
| Jun 30, 2020 | Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trai... | LED display, which provides infusion or patient monitoring values, on the module may have segment... | Class II | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8015. modular infusion pump and monitoring system | If one or more screws or washers are loose or missing causing the battery not to be properly secu... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption ... | Class I | CareFusion 303, Inc. |
| Jun 30, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) | Baxter is updating the device IFU for safety communication regarding cleaning practices. | Class I | Baxter Healthcare Corporation |
| Jun 30, 2020 | Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product ... | Potential for sterile packaging to be compromised¿ | Class II | TELEFLEX MEDICAL INC |
| Jun 29, 2020 | PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usa... | The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. | Class II | Smith & Nephew, Inc. |
| Jun 26, 2020 | InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ul... | A recent FDA inspection at the firm identified that the foil test performed during installation o... | Class II | Steris Corporation |
| Jun 26, 2020 | Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... | Class I | Smiths Medical ASD Inc. |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase te... | Randox have confirmed imprecision of quality control and patient samples when using specific Rand... | Class II | RANDOX LABORATORIES, LTD. |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase ... | Randox have confirmed imprecision of quality control and patient samples when using specific Rand... | Class II | RANDOX LABORATORIES, LTD. |
| Jun 26, 2020 | Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, ... | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific seque... | Class I | Smiths Medical ASD Inc. |
| Jun 26, 2020 | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-us... | This voluntary recall is being conducted following three customer reports of the device cannula d... | Class II | Covidien Llc |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipa... | Randox have confirmed imprecision of quality control and patient samples when using specific Rand... | Class II | RANDOX LABORATORIES, LTD. |
| Jun 26, 2020 | Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-u... | This voluntary recall is being conducted following three customer reports of the device cannula d... | Class II | Covidien Llc |
| Jun 26, 2020 | PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat pati... | While operating the machine in "Run" mode an unexcepted event may occur during the error-checking... | Class II | Precision Valve & Automation,Inc |
| Jun 26, 2020 | BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 an... | The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when ... | Class II | Boss Instruments, Ltd. |
| Jun 25, 2020 | IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.1... | The device may experience an interruption of gas measurement due to a firmware issue, ceasing mea... | Class II | Philips North America, LLC |
| Jun 24, 2020 | syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 | If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 24, 2020 | Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -... | Screws provided in packaging are 5mm shorter than intended | Class II | Arthrex, Inc. |
| Jun 24, 2020 | Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage... | The T-Fix sterile package contains only one sleeve instead of two, The device will not perform a... | Class II | Smith & Nephew, Inc. |
| Jun 24, 2020 | SUTUREFIX ULTRA Suture, Product number 72203855 | A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL d... | Class II | Smith & Nephew, Inc. |
| Jun 24, 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1... | Reagents were shipped to customers after the Use by data indicated on its labeling. | Class III | DNA Genotek Inc. |
| Jun 24, 2020 | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistanc... | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight p... | Class II | Smith & Nephew, Inc. |
| Jun 23, 2020 | TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact... | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact le... | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electro... | The label on the cardbox and the blister show the correct symbols for sterilization using irradia... | Class II | Sutter Medizintechnik GmbH |
| Jun 23, 2020 | Neurosign V4 Intraoperative Nerve monitor family of devices. | Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and... | Class II | The Magstim Company Limited |
| Jun 23, 2020 | TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses | Colored contact lenses were distributed without FDA clearance. | Class II | Chengdu Ai Qin E-commerce Co., Ltd |
| Jun 23, 2020 | MEVION S250 Proton Radiation Treatment System; intended to deliver proton rad... | The perforated screen that divides the inside of the process water tank has a very sharp edge ac... | Class II | Mevion Medical Systems, Inc. |
| Jun 22, 2020 | Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATO... | Sporadic problems with the current software may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2020 | CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi... | CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if ... | Class II | GE Healthcare, LLC |
| Jun 22, 2020 | CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usa... | Software defect may result in disapperance of tag sites during recalculation and lead to addition... | Class II | Biosense Webster (israel), Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
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.