Browse Device Recalls
25 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 25 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 25 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 29, 2019 | Liberty Cycler Cassettes (a disposable cassette that is intended to be used t... | Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Apr 3, 2019 | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1... | Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Nov 5, 2018 | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 05... | Potential for external blood leaks from the dialyzer header | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog ... | Discolored powder has confirmed the presence of a foreign substance | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Num... | Discolored powder has confirmed the presence of a foreign substance | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Num... | Discolored powder has confirmed the presence of a foreign substance | Class III | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 20... | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2... | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failu... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| May 2, 2018 | NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Pa... | The bottles are mislabeled with an incorrect part number. | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 24, 2018 | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usa... | The recalling firm identified a software issue related to the Patient Line Check (PLC) which may ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 14, 2017 | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodial... | When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 5, 2017 | 2008T, Hemodialysis Delivery System Product Indicated for acute and chroni... | While reviewing documentation for the next software release of the 2008T, an R&D technician ident... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Sep 29, 2017 | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter... | The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 21, 2016 | Fresenius 2008K Series : Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 21, 2016 | Fresenius 2008T Series Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 21, 2016 | Fresenius 2008K2 Series : Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 21, 2016 | Fresenius 2008K@home Series : Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change i... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| May 24, 2016 | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-... | Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Mar 10, 2016 | Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K an... | Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Feb 26, 2016 | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute ... | Dialyzer header leak due to possible improper torque | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 18, 2016 | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 In... | On the label calcium (Ca) listed in the right upper corner of the label (red background) incorre... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Dec 15, 2015 | Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR18... | The door latch may not fully close and the door may open unexpectedly. The door may make physica... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 23, 2015 | Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use i... | Dissolution units and replacement motors units do not provide full thermal protection for both th... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 23, 2015 | Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075... | Dissolution units and replacement motors units do not provide full thermal protection for both th... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 23, 2015 | Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the... | Dissolution units and replacement motors units do not provide full thermal protection for both th... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
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.