Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 4, 2016 | (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with insert... | During an evaluation of the product packaging, it was determined that there is a potential for th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 4, 2016 | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... | Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... | Class III | Medtronic Perfusion Systems |
| Feb 4, 2016 | (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting... | During an evaluation of the product packaging, it was determined that there is a potential for th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Feb 4, 2016 | Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. | The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C... | Class I | Draeger Medical, Inc. |
| Feb 4, 2016 | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ... | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that conta... | Class I | Abbott Vascular |
| Feb 3, 2016 | Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipi... | Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fix... | Class II | Zimmer Spine, Inc. |
| Feb 3, 2016 | PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single U... | Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit,... | Class II | Medical Action Industries Inc |
| Feb 2, 2016 | QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an i... | Potential for obtaining a false positive result due to the possibility of endotoxin presence. | Class II | Qiagen Sciences LLC |
| Feb 2, 2016 | Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx O... | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to ho... | Class II | Teleflex Medical |
| Feb 2, 2016 | S3 MedSurg Bed, Model 3005. Stryker Medical | CPU board failures cause fowler (backrest) electronic controls to stop working. | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 2, 2016 | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for ... | The firm discovered that the incorrect lot number was engraved on the product. | Class III | Volk Optical Inc |
| Feb 1, 2016 | Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter... | The Firm discovered that there is a design error which is traceable back to 2012 when a design ch... | Class II | Laserex Systems Inc. |
| Jan 31, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of product archiving not working properly. | Class II | Merge Healthcare, Inc. |
| Jan 31, 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down ... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge Cardio software. Product Usage: Merge Cardio is an integrated car... | Patient information in the header is only found on the first page of the report and not on the su... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | A migrated study that has annotations will display the annotations, but when a prior study is loa... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of the software archiving not working properly. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. Product was distributed under the AMICAS label, Brighto... | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Access used with Ortho PACS software provides medical specialists wi... | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not disp... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Access used with Merge PACS software provides medical specialists wi... | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not disp... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is m... | Communication protocols interfacing with the affected software version with some select instrumen... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | CADstream software. The firm name on the label is Merge Healthcare, Hartland... | The software was not presenting the PURE filter user interface message on DICOM transfer studies.... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, ... | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E... | Class II | Merge Healthcare, Inc. |
| Jan 29, 2016 | Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2... | Screws holding the detector panel in as a result the detector panel could make contact with othe... | Class II | Medtronic Navigation, Inc. |
| Jan 29, 2016 | GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video l... | The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy ... | Class I | Verathon, Inc. |
| Jan 29, 2016 | Trinity Acetabular Shell Product Usage: Total Hip Replacement. | Potential for abrasion of the sterile barrier pouches of the new packaging system. | Class II | Corin USA Limited |
| Jan 29, 2016 | Trinity Acetabular Shell Product Usage Total Hip Replacement. | Potential for abrasion of the sterile barrier pouches of the new packaging system. | Class II | Corin USA Limited |
| Jan 29, 2016 | Trinity Acetabular System Product Usage - Total Hip Replacement. | Potential for abrasion of the sterile barrier pouches of the new packaging system. | Class II | Corin USA Limited |
| Jan 29, 2016 | Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. ... | It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from star... | Class II | Valeant Pharmacueticals International |
| Jan 29, 2016 | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets includi... | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in sur... | Class II | Biomet, Inc. |
| Jan 29, 2016 | PINPOINT Endoscopic Fluorescence Imaging System | It has been determined that the PINPOINT Operator's Manual does not contain validated parameters ... | Class II | Novadaq Technologies Inc. |
| Jan 29, 2016 | software for Syngo Dynamics a Picture Archiving and Communication System ... | Siemens is releasing a software update that addresses an issue of mixing data from multiple patie... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 28, 2016 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-... | Incorrect femoral component distributed | Class II | ConforMIS, Inc. |
| Jan 28, 2016 | Large Volume Paracentesis Kit is packaged in a thermaformed tray which contai... | Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the ab... | Class II | Gi Supply |
| Jan 27, 2016 | UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consi... | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... | Class II | Cook Inc. |
| Jan 27, 2016 | Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral ... | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and t... | Class II | Cook Inc. |
| Jan 27, 2016 | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed.... | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the ... | Class II | Physio-Control, Inc. |
| Jan 27, 2016 | Karma Flexx Wheelchair Manual Wheelchair. | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and cor... | Class II | Karman Healthcare Inc |
| Jan 26, 2016 | Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x... | The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... | Class II | QiG Group LLC |
| Jan 26, 2016 | Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 | The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... | Class II | QiG Group LLC |
| Jan 26, 2016 | AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SIN... | The firm received complaints that the product is shorter in length than indicated on the label. | Class II | Applied Medical Technology Inc |
| Jan 26, 2016 | Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x... | The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... | Class II | QiG Group LLC |
| Jan 25, 2016 | Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Mo... | Siemens' conducting a recall due to a potential issue when using the measurement package of the V... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2016 | BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jan 25, 2016 | Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Ste... | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the inco... | Class II | Sorin Group USA, Inc. |
| Jan 22, 2016 | Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap ... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are co... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap ... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
| Jan 22, 2016 | Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile ... | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are con... | Class II | Covidien LLC |
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.