Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 31, 2019 | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw ... | Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" can... | Class II | ulrich medical USA Inc |
| Dec 31, 2019 | Koios DS Breast <series 1.0>. The device is a software application which assi... | Affected software product versions were found during internal audit to have been marketed for sal... | Class II | Koios Medical, Inc. |
| Dec 30, 2019 | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 ... | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Allura CV20, system code 722031 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Poly G Integris H5000, System code 72246 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF T... | Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. ... | Class II | Solta Medical Inc |
| Dec 30, 2019 | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708... | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intende... | Due to a potential for sterile barrier breach. A complaint was received that indicated the protec... | Class II | Smith & Nephew, Inc. |
| Dec 30, 2019 | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system c... | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | OmniDiagnost Eleva System codes 708028 708027 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | UroDiagnost Eleva, system code 708033 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Cardio Vascular-Allura Centron, system code 722400 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 30, 2019 | Integris Allura 9, system codes 722018 722021 | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... | Class II | Philips North America, LLC |
| Dec 27, 2019 | WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... | Class II | Wright Medical Technology, Inc. |
| Dec 27, 2019 | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 | Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... | Class II | Wright Medical Technology, Inc. |
| Dec 27, 2019 | Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3... | Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, whi... | Class II | Cook Inc. |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Prod... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Pr... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo 924 Safety Screw Spike Set, Product Code 775759 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 24, 2019 | Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusio... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an impla... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantab... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implan... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantab... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 24, 2019 | Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusio... | A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... | Class II | Flowonix Medical Inc |
| Dec 23, 2019 | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft... | Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselN... | Class II | Philips North America, LLC |
| Dec 23, 2019 | Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 | Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed ... | Class II | Zimmer Biomet, Inc. |
| Dec 23, 2019 | MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order #... | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, Inc. |
| Dec 23, 2019 | SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T... | It was identified that due to a potential installation workflow issue, the MR system date could b... | Class II | GE Healthcare, LLC |
| Dec 23, 2019 | PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP) | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, Inc. |
| Dec 23, 2019 | Wave Prep Tubes (1710-03) and single use cups (17--00-24) | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, Inc. |
| Dec 23, 2019 | SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a... | It was identified that due to a potential installation workflow issue, the MR system date could b... | Class II | GE Healthcare, LLC |
| Dec 23, 2019 | SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a... | It was identified that due to a potential installation workflow issue, the MR system date could b... | Class II | GE Healthcare, LLC |
| Dec 23, 2019 | SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is... | It was identified that due to a potential installation workflow issue, the MR system date could b... | Class II | GE Healthcare, LLC |
| Dec 23, 2019 | LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP) | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection ... | Class II | Carroll-Baccari, Inc. |
| Dec 23, 2019 | Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, X... | The manufacturer identified a risk that their products might fail to comply with the cabinet x-ra... | Class II | Nikon Metrology |
| Dec 23, 2019 | Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041... | The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as... | Class II | Jjgc Industria E Comercio De Materials Dentario... |
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE COMPONENT AN-05505 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT JH-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. ... | Firm has received customer complaints regarding failed calibrations and increased imprecision of ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE KIT SL-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow SPINAL ANESTHESIA SET ASA-25090-S | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use... | A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK... | Class II | Custom Healthcare Systems, Inc. |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT AM-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Maximal Barrier Drape ASK-00002-1A | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International 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.