Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 25, 2014 | Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises dilu... | Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated plate... | Class II | Beckman Coulter Inc. |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier ... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 25, 2014 | EpiCenter Plus Microbiology Data Management System software version 6.20A, wh... | The information in the EpiCenter interface translation tables was not updated to match the Bruker... | Class II | Becton Dickinson & Co. |
| Aug 25, 2014 | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... | Class II | Navilyst Medical, Inc |
| Aug 22, 2014 | DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, N... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Aug 22, 2014 | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc,... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Aug 21, 2014 | TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In... | The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen ... | Class II | Maquet Medical Systems USA |
| Aug 21, 2014 | UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices use... | Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may... | Class II | Beckman Coulter Inc. |
| Aug 21, 2014 | Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions... | When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView,... | Class II | Philips Medical Systems, Inc. |
| Aug 20, 2014 | Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusa... | Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal... | Class II | Terumo Cardiovascular Systems Corporation |
| Aug 20, 2014 | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671,... | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using V... | Class II | Ortho-Clinical Diagnostics |
| Aug 19, 2014 | Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD... | An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damag... | Class II | St Jude Medical Cardiac Rhythm Management Division |
| Aug 19, 2014 | 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | Siemens CentraLink Data Management System, software version 14. The Cent... | Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Da... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Mod... | The hook does not securely hold the footplate in vertical position. Therefore the footplate can f... | Class II | Philips Medical Systems, Inc. |
| Aug 19, 2014 | ADVIA Centaur Immunoassay System (including refurbished units), This syst... | The firm has identified an issue with patient demographic information sent to the LIS from the AD... | Class II | Siemens Healthcare Diagnostics |
| Aug 19, 2014 | Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Mo... | The hook does not securely hold the footplate in vertical position. Therefore the footplate can f... | Class II | Philips Medical Systems, Inc. |
| Aug 19, 2014 | 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 19, 2014 | ADVIA Centaur XP Immunoassay System (including refurbished units), This s... | The firm has identified an issue with patient demographic information sent to the LIS from the AD... | Class II | Siemens Healthcare Diagnostics |
| Aug 19, 2014 | STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... | ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... | Class I | ICU Medical, Inc. |
| Aug 18, 2014 | Monaco The Monaco system is used to make treatment plans for patients wit... | Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic ... | Class II | Elekta, Inc. |
| Aug 18, 2014 | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provi... | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by th... | Class II | Varian Medical Systems, Inc. |
| Aug 18, 2014 | Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Irel... | Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monito... | Class II | Integra LifeSciences Corp. |
| Aug 18, 2014 | Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per ... | The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn ... | Class II | Hitachi Medical Systems America Inc |
| Aug 18, 2014 | Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in v... | Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 18, 2014 | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for pat... | When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Com... | Class II | Elekta, Inc. |
| Aug 15, 2014 | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Ac... | Product was distributed past its expiration date. | Class II | Apollo Endosurgery Inc |
| Aug 15, 2014 | Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., ... | The peel strength of the inner blister may have been below internal validated requirements. The ... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 15, 2014 | Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp.,... | The peel strength of the inner blister may have been below internal validated requirements. The ... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 15, 2014 | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174A... | Medtronic has decided to discontinue production and distribution of this low-volume product. | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Aug 15, 2014 | Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser... | Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) becau... | Class II | Lumenis, Inc. |
| Aug 15, 2014 | Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica ... | The peel strength of the inner blister may have been below internal validated requirements. The ... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 15, 2014 | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JR... | Potential issues with the ProVue driver have been identified which may cause data to be misassoci... | Class II | Data Innovations, LLC |
| Aug 14, 2014 | Dimension Vista¿ HbA1c | In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 14, 2014 | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The ... | SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because t... | Class II | Sam Medical Products |
| Aug 14, 2014 | Synthes Small Electric Drive (SED). For use in general traumatology. | The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in revers... | Class II | The Anspach Effort, Inc. |
| Aug 14, 2014 | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ ... | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unope... | Class II | Biomedix, Inc. |
| Aug 13, 2014 | Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use wi... | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Vapotherm, Inc. |
| Aug 13, 2014 | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Lo... | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Vapotherm, Inc. |
| Aug 13, 2014 | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use wit... | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Vapotherm, Inc. |
| Aug 13, 2014 | ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (S... | The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... | Class II | Siemens Healthcare Diagnostics |
| Aug 13, 2014 | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for pat... | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval noti... | Class II | Smith & Nephew, Inc. |
| Aug 13, 2014 | Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use... | Water may leak into the center gas lumen of the Patient Circuit | Class II | Vapotherm, Inc. |
| Aug 13, 2014 | Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use w... | Disposable Patient Circuit that allows water to leak into the center gas lumen | Class II | Vapotherm, 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.