Browse Device Recalls
408 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 408 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 408 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Feb 6, 2018 | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product... | Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with ... | Class II | Baxter Healthcare Corporation |
| Dec 21, 2017 | MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 8... | Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was... | Class II | Baxter Healthcare Corporation |
| Oct 6, 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTI... | Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lu... | Class II | Baxter Healthcare Corporation |
| Jul 27, 2017 | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... | A leak may allow for microbial contamination of the sterile fluid path. | Class II | Baxter Healthcare Corporation |
| Jul 5, 2017 | HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product... | Baxter Healthcare Corporation has been made aware that users may not be following the instruction... | Class II | Baxter Healthcare Corporation |
| Jul 5, 2017 | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usa... | Baxter Healthcare Corporation has been made aware that users may not be following the instruction... | Class II | Baxter Healthcare Corporation |
| Feb 15, 2017 | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... | Firm has received reports of device operators failing to adhere to instructions for use pertainin... | Class II | Baxter Healthcare Corporation |
| Jan 26, 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... | SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... | Class II | Baxter Healthcare Corporation |
| Jan 4, 2017 | Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system i... | Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... | Class II | Baxter Healthcare Corporation |
| Jan 4, 2017 | Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system i... | Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... | Class II | Baxter Healthcare Corporation |
| Dec 16, 2016 | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in... | Customer complaints received for the presence of leaks | Class II | Baxter Healthcare Corporation |
| Sep 28, 2016 | Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In... | A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... | Class II | Baxter Healthcare Corp. |
| Aug 24, 2016 | 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacter... | Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the... | Class I | Baxter Corporation Englewood |
| Feb 16, 2016 | Automated peritoneal dialysis (APD) cycler | Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructi... | Class II | Baxter Healthcare Corp. |
| Dec 4, 2014 | Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Y... | Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because the... | Class II | Baxter Corporation Englewood |
| Jul 14, 2014 | ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamb... | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... | Class II | Baxter Healthcare Corp |
| Jul 14, 2014 | ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***... | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... | Class II | Baxter Healthcare Corp |
| Jul 14, 2014 | ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Cham... | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... | Class II | Baxter Healthcare Corp |
| Jul 11, 2014 | FlowCOUPLER. An implantable device that is used to detect blood flow in ves... | Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some un... | Class II | Baxter Healthcare Corporation |
| Jun 17, 2014 | Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... | Inadequate iodine and packaging related defects. | Class II | Baxter Healthcare Corp. |
| Apr 28, 2014 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... | Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... | Class II | Baxter Healthcare Corporation |
| Feb 7, 2014 | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... | Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... | Class I | Baxter Healthcare Corp. |
| Dec 3, 2013 | ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... | Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... | Class II | Baxter Corporation Englewood |
| Sep 25, 2013 | Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp... | Incomplete foil seal on one lot of sterile product. | Class II | Baxter Healthcare Corp. |
| Sep 24, 2013 | SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc... | Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ... | Class II | Baxter Healthcare Corp. |
| Sep 4, 2013 | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... | The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... | Class II | Baxter Healthcare Corp. |
| Aug 30, 2013 | Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured ... | Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 | Class II | Baxter Healthcare Corp. |
| Aug 22, 2013 | Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Si... | Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer... | Class II | Baxa Corporation |
| Jun 10, 2013 | SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used... | Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion ... | Class II | Baxter Healthcare Corp. |
| Jun 7, 2013 | Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administrat... | Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... | Class II | Baxter Healthcare Corp. |
| Jun 7, 2013 | Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for ... | Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... | Class II | Baxter Healthcare Corp. |
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.