Browse Device Recalls
146 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 146 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 146 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 25, 2025 | 5008X CAREsystem +CLiC +CDX; | Several software anomalies with the potential to impact patient treatment, of which one includes ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 29, 2025 | Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F16... | To provide further information to the user to ensure proper use of the medical device. the caps h... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 29, 2025 | 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the followin... | Potential of blood leak occurring between the lower port of the venous chamber and the tubing inc... | Class II | Fresenius Medical Care Holdings, Inc. |
| Dec 5, 2024 | Dialyzer Optiflux 160NRe | Potential for internal blood leaks due to cracked polyurethane | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2024 | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) wit... | Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Mode... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare p... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model N... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part,... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 3, 2024 | RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare p... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 16, 2024 | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be u... | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point ran... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump ... | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 17, 2024 | Blood Pump Rotor, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 8, 2024 | Novalung sensor box is a component of the Novalung Console (F30000162)-Indica... | Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Safe Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Catheter Ext. 6 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 18 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Adapter 4 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Oct 24, 2023 | Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ... | Class III | Fresenius Medical Care Holdings, Inc. |
| Oct 10, 2023 | Stay Safe Cap | Updating the labeling to include additional warnings and contraindications for potential side eff... | Class II | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. CDX BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis System without CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. CDX W/BIBAG BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T GEN 2 Bibag without CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis System w/Bibag | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T Hemodialysis SYS, with CDX | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Sep 6, 2023 | 2008T HD SYS. W/O CDX BLUESTAR | Potential PCBA leaching from tubing of hemodialysis machines. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 b... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, ... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Oct 4, 2022 | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jul 27, 2022 | 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute a... | (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, ha... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 21, 2022 | AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended ... | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic comp... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 21, 2022 | AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended... | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic comp... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 16, 2022 | AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic P... | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 16, 2022 | AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic P... | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 1, 2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | The product was potentially exposed to below-recommended storage temperatures, which may cause le... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, 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. |
| Dec 7, 2021 | Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- ... | Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the N... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 3, 2021 | AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - ... | AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideli... | Class II | Fresenius Medical Care Holdings, 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.