Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 19, 2016 | Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9... | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... | Class II | Villa Radiology Systems LLC |
| Feb 18, 2016 | Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion ca... | The label on the outer packaging does not match the product inside and intended use of the device. | Class II | Synthes (USA) Products LLC |
| Feb 17, 2016 | EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum c... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 16, 2016 | 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 16, 2016 | 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 16, 2016 | 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Scr... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 16, 2016 | 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 16, 2016 | 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Scr... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 16, 2016 | 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, ... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 16, 2016 | 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and ... | Labeling does not match the cleared indications for use in the United States and Canada. | Class II | Synthes (USA) Products LLC |
| Feb 12, 2016 | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Mod... | Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mi... | Class II | Biomet Spine, LLC |
| Feb 11, 2016 | KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) ... | AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. | Class II | AcuFocus, Inc. |
| Feb 11, 2016 | M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... | Class II | Zimmer Biomet, Inc. |
| Feb 9, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | A report can be confirmed with the incorrect patient demographics resulting in it being saved und... | Class II | Merge Healthcare, Inc. |
| Feb 9, 2016 | Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... | Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... | Class II | Medtronic Neuromodulation |
| Feb 8, 2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner... | Class II | Ormco/Sybronendo |
| Feb 5, 2016 | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B... | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possi... | Class II | Beckman Coulter Inc. |
| Feb 5, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., H... | When measuring a lesion on an unmagnified mammography image then performing the same measurement ... | Class II | Merge Healthcare, 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 |
| 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 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 | 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 | 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 | 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 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 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 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 22, 2016 | 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. | 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can... | Class II | 3M Company - Health Care Business |
| Jan 21, 2016 | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of thr... | The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug... | Class II | EKOS Corporation |
| Jan 20, 2016 | Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac... | Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. | Class II | Zimmer Biomet, Inc. |
| Jan 20, 2016 | Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70... | Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. | Class II | Cook Inc. |
| Jan 19, 2016 | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Pe... | The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HI... | Class III | Sorin Group USA, Inc. |
| Jan 18, 2016 | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 In... | On the label calcium (Ca) listed in the right upper corner of the label (red background) incorre... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 15, 2016 | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Powe... | The product is labeled with an expiration date that is past its shelf life. | Class II | Spectranetics Corp. |
| Jan 15, 2016 | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product... | Customers reported issues when scanning medications with the scanners. When a user scans a medic... | Class II | CareFusion 303, Inc. |
| Jan 11, 2016 | Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... | Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... | Class II | Medtronic Neuromodulation |
| Jan 5, 2016 | Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. I... | Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product ... | Class II | Bard Peripheral Vascular Inc |
| Jan 5, 2016 | Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. I... | Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm ... | Class II | Bard Peripheral Vascular Inc |
| Dec 29, 2015 | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Pr... | Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) | Class II | Pharmacaribe llc |
| Dec 23, 2015 | Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. | The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instruct... | Class II | Stryker Howmedica Osteonics Corp. |
| Dec 21, 2015 | Hip Preservation System Signature Series PreBent Burs under the following lab... | Metal shavings released from burs during use are due to contact between the bur and the hood of t... | Class II | ConMed 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.