Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 4, 2019 | REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, F... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, Inc. |
| Oct 4, 2019 | Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. | Product was manufactured utilizing an expired inner body. | Class II | Cordis Corporation |
| Oct 4, 2019 | Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance Sy... | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. | Class II | Neocis Inc. |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5052. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an ob... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an obser... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic E... | Certain clip appliers have an increase in misloading and/or jamming related complaints that may b... | Class II | Teleflex Medical |
| Oct 4, 2019 | Roche Homocysteine-In vitro test for the quantitative determination of total ... | Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 an... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Mani... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, Inc. |
| Oct 4, 2019 | Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System... | The firm became aware of a cleaning solution leaking issue from the middle staining module of the... | Class II | Ventana Medical Systems Inc |
| Oct 4, 2019 | WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543... | Certain clip appliers have an increase in misloading and/or jamming related complaints that may b... | Class II | Teleflex Medical |
| Oct 4, 2019 | REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing,... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, Inc. |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pr... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, Inc. |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopco... | There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of ... | Class II | ICU Medical, Inc. |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an ob... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2019 | Prismaflex Control Unit, software versions below 7.21 | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss... | Class II | Baxter Healthcare Corporation |
| Oct 3, 2019 | Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos ... | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... | Class II | Cook Inc. |
| Oct 3, 2019 | Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to... | Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wa... | Class II | Howmedica Osteonics Corp. |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a... | Class II | Philips North America, LLC |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave... | One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier... | Class II | Datascope Corp. |
| Oct 3, 2019 | Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer | There is a potential for Medtronic programmer and remote monitoring software applications to disp... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Oct 3, 2019 | Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embr... | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... | Class II | Cook Inc. |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 2, 2019 | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) | When the user tilts the transmitted light arm of the microscope to the end of its axis range, las... | Class II | Zeiss, Carl Inc |
| Oct 2, 2019 | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ... | The devices are not labelled correctly. End users impacted by this issue may experience a proced... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Oct 2, 2019 | 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical... | Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as i... | Class II | Exactech, Inc. |
| Oct 2, 2019 | Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device ... | Inner draw rod, which threads into the cage may potentially be separated from the proximal knob o... | Class II | Medicrea International |
| Oct 2, 2019 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm ... | There is a potential for the screws to have become loosened during ultrasonic cleaning of the kno... | Class II | Pega Medical Inc. |
| Oct 1, 2019 | Aesculap Sterile disposable fleece drape, Product code: GA414, individually p... | Packaging seal integrity not validated resulting in a lack of sterility assurance. | Class II | Aesculap Implant Systems LLC |
| Oct 1, 2019 | 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 74960... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Ve... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-85... | Screws provided in the device package are 6 mm longer than intended. | Class II | Arthrex, Inc. |
| Oct 1, 2019 | Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00,... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Si... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) | Product was distributed prior to approval or clearance from FDA. | Class II | Monarch Medical Technologies |
| Oct 1, 2019 | BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lu... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen... | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a b... | Class II | Bard Peripheral Vascular Inc |
| Oct 1, 2019 | Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 1, 2019 | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... | NIBP valve assembly board subject to this recall includes enhancements that are not included in t... | Class II | Mindray DS USA, Inc. dba Mindray North America |
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.