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 |
|---|---|---|---|---|
| Apr 6, 2016 | Confocal GI Scope Product Usage: Intended to provide optical visualizatio... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, the... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Gastroscope Intended to provide optical visualization of and therapeutic acc... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Choledochoscope Intended to provide optical visualization of and therapeutic... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Confocal GI Scope Intended to provide optical visualization of an therapeuti... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Choledocho-Nephroscope Intended to provide optical visualization of and ther... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Duodenoscope Product Usage: Intended to provide optical visualization of ... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Cystoscope Intended to provide optical visualization of and therapeutic acce... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ureteroscope Intended to provide optical visualization of and therapeutic ac... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not rest... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Gastroscope Product Usage: Intended to provide optical visualization of a... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ultrasound Gastroscope Intended to provide optical visualization of, ultraso... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ultrasound Bronchoscope Intended to provide optical visualization of, ultras... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Signmoidoscope Intended to provide optical visualization of, therapeutic acc... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ... | If used, the optional Swap feature copies programming parameters from the external pulse generato... | Class II | Nuvectra |
| Apr 6, 2016 | Ultrasound Gastroscope Product Usage: Intended to provide optical visuali... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | Laryngo Stroboscope Product Usage Intended to provide optical visualization ... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not ... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Colonoscope Product Usage: Intended to provide optical visualization of a... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | EZ Slide Battery/line powered hydraulic table with removable leg section and ... | The potential exists within the identified tables that incorrectly manufactured parts have been u... | Class II | Skytron, Div. The KMW Group, Inc |
| Apr 6, 2016 | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | Intubation Scope Intended to provide optical visualization of, therapeutic a... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Colonoscope Intended to provide optical visualization of and therapeutic acc... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Bronchoscope Intended to provide optical visualization of and therapeutic ac... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Signmoidoscope Product Usage: Intended to provide optical visualization o... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 5, 2016 | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 ... | During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 dele... | Class II | Roche Molecular Systems, Inc. |
| Apr 5, 2016 | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) ... | Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up ... | Class II | Leica Microsystems, Inc. |
| Apr 5, 2016 | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the... | Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the e... | Class II | Leica Microsystems, Inc. |
| Apr 5, 2016 | Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100... | CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following... | Class II | Ceg Enterprises Llc |
| Apr 4, 2016 | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor... | In some instances, the system will lock tabs within a study, even when a second user does not hav... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part ... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripher... | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | iConnect Enterprise Archive software. | The versions allow images to be stored without pixel data, resulting in the system not being able... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is ... | The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartla... | When taking measurements from images on the Cardio workstation or from the US cart, numbers are n... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger cli... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive when used with RadSuite. The firm name on the la... | The software produced a number of "do not route" exceptions, which may result in potential pati... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains ... | Product resistance has fallen outside of label claim within expiry. | Class II | Mesa Laboratories Inc |
| Apr 4, 2016 | Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 | Device packaging may not be sealed. | Class II | Stryker Sustainability Solutions |
| Apr 4, 2016 | Merge Eye Station and Merge Eye Care PACS. | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may d... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare. | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Me... | System locks up which may result in potential patient injury or delay in diagnosis or treatment. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Potential exists for an incorrect patient image being displayed which could result in the delay i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software using EchoIMS. The firm name on the label is Merge Hea... | A situation can occur allowing two physicians to access the same study report in EchoIMS when lau... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID #... | This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped afte... | Class II | Synthes (USA) Products LLC |
| Apr 4, 2016 | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling i... | An error message can occur resulting in the prior studies being unavailable for viewing. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-0001... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Pr... | Under certain conditions, the cables used with the Hemo system during a patient procedure could s... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software. | Cardio study list does not show STAT studies without refreshing. | Class II | Merge Healthcare, 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.