Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 27, 2017 | MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... | Unapproved change made by the supplier. | Class II | Zimmer Biomet, Inc. |
| Feb 27, 2017 | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 | Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US in... | Class II | CORENTEC CO., LTD |
| Feb 24, 2017 | BrightView SPECT model number 882480 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ... | Due to some cards in this lot reported to have experienced variations in results, (verified by wa... | Class II | Helena Laboratories, Inc. |
| Feb 24, 2017 | BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class III | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536... | HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a si... | Class I | Philips North America, LLC |
| Feb 24, 2017 | BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView XCT model number 882482 BrightView and BrightView X are gamma cam... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Manometer, 550 ml three-Way Stopcock; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.)... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Pa... | The bed exit alarm may not function properly if the alarm has been armed for a period longer than... | Class II | Hill-Rom, Inc. |
| Feb 23, 2017 | Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... | Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... | When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The ... | The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states ... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2017 | Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preserva... | Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adap... | Class II | Streck |
| Feb 23, 2017 | Ziehm Imaging solo FD Mobile Fluoroscopic C-arm | During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel wa... | Class II | Ziehm Imaging Inc |
| Feb 23, 2017 | Thoracentesis/ Paracentesis Kit 10/CS; STERILE; | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 23, 2017 | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: ... | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 23, 2017 | JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G ... | The integrity of the sterile packaging is potentially compromised. | Class II | Carefusion 2200 Inc |
| Feb 22, 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide c... | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... | Class I | Medtronic Neurosurgery |
| Feb 22, 2017 | ARTIS Q, Interventional Fluroscopic x-ray system | In Artis systems with A100G generators, a component can be affected by aging which could result i... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 22, 2017 | INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Strai... | Incorrect device was packaged. | Class II | Ace Surgical Supply Co., Inc. |
| Feb 21, 2017 | OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems | OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging f... | Class II | GE OEC Medical Systems, Inc |
| Feb 21, 2017 | VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Ide... | Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can ... | Class II | Ortho-Clinical Diagnostics |
| Feb 21, 2017 | MicroAire K-Wires | Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of... | Class II | MicroAire Surgical Instruments, LLC |
| Feb 20, 2017 | SmartTools Knee System Orthopedic Stereotaxic Instrument | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Feb 20, 2017 | Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs... | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | Class II | Siemens Medical Solutions USA Inc. |
| Feb 20, 2017 | Poly Component Trial, MPCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGu... | CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.... | Class II | CareFusion 303, Inc. |
| Feb 20, 2017 | Poly Component Trial, PS, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: ... | Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 20, 2017 | MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. M... | CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter beca... | Class II | CareFusion 303, Inc. |
| Feb 20, 2017 | Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 | Potential for poly tip of the mallet to come off during use. Potential for foreign material in t... | Class II | Signal Medical Corporation |
| Feb 20, 2017 | Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mo... | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | Class II | Siemens Medical Solutions USA Inc. |
| Feb 20, 2017 | Poly Component Trial, CR, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices us... | Incorrect priming volume printed on the device package. | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Feb 20, 2017 | Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs... | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | Class II | Siemens Medical Solutions USA Inc. |
| Feb 20, 2017 | Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza ... | Software updates | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2017 | Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile P... | The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. | Class II | Siemens Medical Solutions USA Inc. |
| Feb 20, 2017 | Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage:... | Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads du... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 20, 2017 | Poly Component Trial, UCCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 17, 2017 | .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST a... | Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X... | Class II | Acumed LLC |
| Feb 17, 2017 | various polyethylene implants Custom parts Product Usage: Custom | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, Inc. |
| Feb 17, 2017 | Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscop... | Fujifilm is recalling multiple endoscopes after a retrospective review. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Feb 17, 2017 | various polyethylene implants Extremities, Shoulders and Elbows BioModular... | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, Inc. |
| Feb 17, 2017 | various polyethylene implants Hips Active Articulation ArComXL Bearings A... | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, Inc. |
| Feb 17, 2017 | various polyethylene implants BIO PLUG 10MM Product Usage: Non-weig... | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, Inc. |
| Feb 17, 2017 | various polyethylene implants Knees Revision Tibial Tray Systems Oxford P... | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, 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.