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 |
|---|---|---|---|---|
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended fo... | Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Di... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 8, 2016 | Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The produc... | The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 ... | Class II | Pelton & Crane / Marus / DCI Equipment / KaVo |
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No.... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 8, 2016 | Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Dia... | ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specificati... | Class II | ICU Medical, Inc. |
| Mar 7, 2016 | Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 ... | Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 7, 2016 | VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Ac... | In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the fi... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Mar 7, 2016 | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Deli... | When editing the isocenter or the couch position of the plan while in the treatment workflow (in ... | Class II | Viewray Incorporated |
| Mar 7, 2016 | ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 1069757... | Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2016 | Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Reports relating to unintended patient or operator burns or operator electric shock for some of I... | Class II | Integra LifeSciences Corp. |
| Mar 7, 2016 | Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 ... | Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 7, 2016 | Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Reports relating to unintended patient or operator burns or operator electric shock for some of I... | Class II | Integra LifeSciences Corp. |
| Mar 4, 2016 | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management ... | Complaints were received of restricted/inaccurate flow rate. | Class II | C.R. Bard, Inc. |
| Mar 4, 2016 | Extended Brilliance Workspace NM Nuclear medicine image display and processin... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 4, 2016 | Extended Brilliance Workspace NM Special Nuclear medicine image display and p... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 4, 2016 | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are... | Vascular Solutions became aware of a potential problem with the click version of the Guardian II ... | Class I | Vascular Solutions, Inc. |
| Mar 4, 2016 | The Spectra-System Dental Implant 2008 system is comprised of dental implant ... | Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees d... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 4, 2016 | IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medi... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 3, 2016 | Hand-Held Scanner USB IT3800 For sample identification and tracking when use... | The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identifie... | Class II | Roche Molecular Systems, Inc. |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 c... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 6... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Sof... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 8... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 4... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ... | During functional testing of devices after real time aging, it was determined that product failed... | Class II | ArthroCare Corporation |
| Mar 3, 2016 | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Sea... | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in ... | Class II | Dynarex Corporation |
| Mar 3, 2016 | Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | The seal between the balloon and the housing may leak. | Class II | Circulatory Technology Inc |
| Mar 3, 2016 | Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 ... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 3, 2016 | Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Nu... | Compromised sterility due to breach of barrier | Class II | Covidien LLC |
| Mar 2, 2016 | Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images ... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of ... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems.... | Radiation emissions which exceeded the limit in the performance standard were detected during mai... | Class II | GE Inspection Technologies, LP |
| Mar 2, 2016 | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK... | Possible presence of foreign material (rust). | Class II | CMP Industries, Llc |
| Mar 2, 2016 | Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash a... | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2016 | Siemens SOMATOM Definition: Intended to produce cross-sectional images of the... | Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients wit... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 1, 2016 | SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body... | Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction... | Class II | GE Medical Systems, LLC |
| Mar 1, 2016 | VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Gu... | Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision P... | Class II | Alcon Research, Ltd. |
| Feb 29, 2016 | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instr... | There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point ... | Class II | Nidek Inc |
| Feb 29, 2016 | Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffe... | Lot was not functioning properly and not exhibiting the correct physical properties. | Class III | AMS Diagnostics, LLC |
| Feb 29, 2016 | ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile ... | Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to... | Class II | Karl Storz Endovision, Inc. |
| Feb 29, 2016 | Gomco Style Circumcision Clamp Trays is an instrument used to compress the fo... | Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumci... | Class II | Cardinal Health |
| Feb 29, 2016 | The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera... | Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts a... | Class II | Richard Wolf Medical Instruments Corp. |
| Feb 26, 2016 | Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide c... | The firm has received one report of values for patient height and weight being switched when inpu... | Class II | Spacelabs 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.