Browse Device Recalls
394 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 394 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 394 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 17, 2020 | Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi... | Potential disconnection of tubing set. | Class II | Baxter Healthcare Corporation |
| Apr 7, 2020 | Prismaflex Control Unit | Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distr... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices s intended to be used in the an... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Mar 5, 2020 | GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to ... | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner t... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2020 | Prismaflex System, Prismaflex Control Unit | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the pr... | Class II | Baxter Healthcare Corporation |
| Jan 3, 2020 | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... | ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... | Class II | ROi CPS LLC |
| Dec 12, 2019 | ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8... | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... | Class II | Baxter Healthcare Corporation |
| Dec 12, 2019 | Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8... | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for... | Class II | Baxter Healthcare Corporation |
| Nov 15, 2019 | Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L | There is the potential presence of particular matter in the header caps of ten lots the Revaclear... | 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 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 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 |
| Sep 19, 2019 | TherMax Blood Warmer Unit | TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2019 | EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following produ... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Aug 13, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100... | Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| Jun 27, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 P... | EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| May 31, 2019 | REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear ... | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during t... | Class II | Baxter Healthcare Corporation |
| May 31, 2019 | REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear ... | There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during t... | Class II | Baxter Healthcare Corporation |
| Dec 11, 2018 | AMIA Automated Peritoneal Dialysis System Product Usage: It is intended ... | Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... | Class II | Baxter Healthcare Corporation |
| Dec 11, 2018 | Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended... | Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... | Class II | Baxter Healthcare Corporation |
| Nov 2, 2018 | GEM Coupler Forceps, GEM4183C, packaged individually. | Potential presence of rust on Coupler Forceps (GEM4183C). | Class II | Baxter Healthcare Corporation |
| Oct 10, 2018 | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f... | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2018 | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 | If an operator attempts to manually program a Basic Infusion for a drug that is not included in t... | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used t... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Sep 12, 2018 | EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to ... | Potential ability to leak once used for compounding. | Class II | Baxter Healthcare Corporation |
| Jul 12, 2018 | power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguy... | There were instances where the power cord socket detached from the back of the AMIA cycler when t... | Class II | Baxter Healthcare Corporation |
| Jun 21, 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), pro... | The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pum... | Class II | Baxter Healthcare Corporation |
| May 30, 2018 | FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL ... | Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufactu... | Class II | Baxter Healthcare Corporation |
| May 8, 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), inf... | The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... | Class II | Baxter Healthcare Corporation |
| May 8, 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), inf... | The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Ex... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exa... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Cont... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Con... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Cont... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Contr... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Cont... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
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.