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 |
|---|---|---|---|---|
| Dec 8, 2023 | XScribe Cardiac Stress Testing System, version 6, with below product names an... | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... | Class II | Baxter Healthcare Corporation |
| Dec 8, 2023 | Q-Stress Cardiac Stress Testing System, version 6, with below product name / ... | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... | Class II | Baxter Healthcare Corporation |
| Dec 8, 2023 | XScribe CP Cardiac Stress Testing System, version 6, with below product names... | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency F... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC12... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5m... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) P... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, ... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 15... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: ... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 9340... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG04... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the fo... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883 | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 m... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Dec 6, 2023 | Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100,... | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products ... | Class II | Baxter Healthcare Corporation |
| Nov 15, 2023 | Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test o... | Class II | Baxter Healthcare Corporation |
| Oct 13, 2023 | Novum IQ Syringe infusion system, Product Code 40800BAXUS | Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter ident... | Class I | Baxter Healthcare Corporation |
| Oct 4, 2023 | HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000... | Progressa+ beds have the potential for static buildup from the casters and/or power drive. This s... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | Welch Allyn Connex Spot Monitor | Product is being recalled due to the improper placement of a copper tape on the back of the liqui... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ... | Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the... | Class II | Baxter Healthcare Corporation |
| Jun 19, 2023 | GEM FLOW COUPLER Monitor, PN 5156-00000-011 | An issue was identified where the LCD monitor display may not indicate the correct active channel... | Class II | Baxter Healthcare Corporation |
| Jun 15, 2023 | SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... | Class I | Baxter Healthcare Corporation |
| Jun 15, 2023 | The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 35... | A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and ... | Class I | Baxter Healthcare Corporation |
| May 19, 2023 | Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Ce... | Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring featur... | Class II | Baxter Healthcare Corporation |
| May 19, 2023 | NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed | Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring featur... | Class II | Baxter Healthcare Corporation |
| May 18, 2023 | Allen Advance Chest Support with Pad | Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber... | Class II | Baxter Healthcare Corporation |
| Mar 31, 2023 | Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) ... | There is a potential for mattress cover damage (delamination) which may result in fluid absorptio... | Class II | Baxter Healthcare Corporation |
| Mar 27, 2023 | GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: ... | The product is brittle and potentially crumbling upon handling or when being removed from its pac... | Class II | Baxter Healthcare Corporation |
| Mar 20, 2023 | ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medi... | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. | Class II | Baxter Healthcare Corporation |
| Feb 22, 2023 | Automated Peritoneal Dialysis System. Used for automatic control of dialysis... | The electrical safety testing was not properly performed on the impacted devices and additional t... | Class II | Baxter Healthcare Corporation |
| Feb 1, 2023 | Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accesso... | MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been inc... | Class II | Baxter Healthcare Corporation |
| Jan 25, 2023 | Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of ind... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilator... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventila... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventil... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re... | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and a... | Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA... | Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re... | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Class II | Baxter Healthcare Corporation |
| Nov 23, 2022 | Revaclear 300 dialyzers. Indicated for treatment of chronic and acute re... | Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak | Class II | Baxter Healthcare Corporation |
| Oct 31, 2022 | Baxter Electrocardiograph, ELI 380 -DCS21 | One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer ... | Class II | Baxter Healthcare Corporation |
| Oct 18, 2022 | Hill-Rom Progressa Bed System | The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the... | Class II | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for ... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System,... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 20, 2022 | Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104.... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | 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.