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 |
|---|---|---|---|---|
| Jun 7, 2019 | Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products ... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Produ... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE6... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 P... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535... | The AC power module may fail at a higher than expected rate. If a fully charged battery is not p... | Class II | Philips North America, LLC |
| Jun 7, 2019 | 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REP... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, R... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, R... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBT... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, ... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re... | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... | Class III | Polymer Technology Systems, Inc. |
| Jun 7, 2019 | 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB,... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... | Class III | Polymer Technology Systems, Inc. |
| Jun 7, 2019 | Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbe... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers ... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, EC... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFV... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Produ... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 7, 2019 | Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401... | The protective material used in the manufacture of the products could potentially provide inadequ... | Class II | Burlington Medical, LLC |
| Jun 6, 2019 | OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturi... | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the... | Class II | Skeletal Kinetics, Llc |
| Jun 6, 2019 | Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: ... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model N... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 1... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model ... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone... | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva s... | Class II | DRG Instruments GmbH |
| Jun 6, 2019 | Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Num... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model N... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Nu... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Num... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Numb... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturin... | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the... | Class II | Skeletal Kinetics, Llc |
| Jun 6, 2019 | Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Numbe... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Num... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 6, 2019 | Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Numb... | Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movabl... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2019 | PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0.... | The monitor displays an error message . The error message states "internal error restart or serv... | Class II | GETINGE US SALES LLC |
| Jun 5, 2019 | Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used ... | Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with ... | Class I | Qiagen Sciences LLC |
| Jun 4, 2019 | SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Ite... | The products do not have sufficient data to support the labeled shelf life of 10 years. | Class II | Zimmer Biomet, Inc. |
| Jun 4, 2019 | Powerheart¿ G5 Automatic AED | Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determi... | Class II | Cardiac Science Corporation |
| Jun 4, 2019 | inLight Medical LED Pads used with Polychromatic light technology system | LED pads with cord connectors that have v-shaped notches may not have been assembled properly. Th... | Class III | Inlightened Partners LLC |
| Jun 4, 2019 | SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 4, 2019 | Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usa... | The products do not have sufficient data to support the labeled shelf life of 10 years. | Class II | Zimmer Biomet, Inc. |
| Jun 4, 2019 | SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, ... | The potential sporadic performance problems may cause scanning workflow interruptions and unexp... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 3, 2019 | BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 3... | The products have been confirmed to have reduced or no additive within the tube reservoir. The t... | Class II | Becton Dickinson & Company |
| Jun 3, 2019 | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure ... | Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 ... | Class II | Suntech Medical, Inc. |
| Jun 3, 2019 | Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomograp... | The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cov... | Class II | Philips Medical Systems (Cleveland) 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.