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 |
|---|---|---|---|---|
| Aug 5, 2016 | e.cam and Symbia E gamma camera systems with patient beds To detect or ima... | "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 5, 2016 | Syngo.x picture archiving and communication system Syngo.x is a software s... | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 5, 2016 | CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the... | Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ... | Class II | Medtronic Inc. |
| Aug 5, 2016 | Nylon Surgical Suture for human use and vet use, sold under brand name Riverl... | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subs... | Class II | Riverpoint Medical, LLC |
| Aug 4, 2016 | MISAGO RX Self Expanding Peripheral Stem | During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product sp... | Class II | Terumo Medical Corp |
| Aug 4, 2016 | AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C i... | Belt clip may become detached causing electronic components to be exposed. | Class II | AirStrip Technologies, Inc. |
| Aug 4, 2016 | Infant Warmer System (IWS) | GE Healthcare has recently become aware of a potential safety issue related to loose screws in th... | Class II | GE Healthcare, LLC |
| Aug 4, 2016 | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultras... | Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System beca... | Class II | Toshiba American Medical Systems Inc |
| Aug 4, 2016 | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. | Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Aug 4, 2016 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 7... | Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System t... | Class II | Beckman Coulter Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-... | Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Aug 3, 2016 | BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D... | Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cart... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 2, 2016 | catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal... | A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose In... | Class II | Becton Dickinson & Company |
| Aug 2, 2016 | Syngo Plaza picture archiving and communication system (PAC) (PACS) intended ... | Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 2, 2016 | Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smoot... | The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and o... | Class II | Zimmer Biomet, Inc. |
| Aug 2, 2016 | Certegra Workstation used in conjunction with Medrad Stellant CT Injection Sy... | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exh... | Class II | Bayer Healthcare |
| Aug 2, 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. | Class III | Alere San Diego, Inc. |
| Aug 2, 2016 | Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner ca... | Certain lots of the acid solution in Acecide-C are degrading faster than normal. | Class II | Best Sanitizers Inc |
| Aug 2, 2016 | Randox Lipase (Colorimetric) Product Usage: A lipase test system is a dev... | According to the firm carry over was observed when the Lipase test is run directly before or afte... | Class II | Randox Laboratories Ltd. |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Aug 2, 2016 | Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, proc... | Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows ... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Aug 2, 2016 | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... | On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha... | Class I | Greatbatch Medical |
| Aug 1, 2016 | YSIO Max Product Usage: The Ysio Max is a radiographic system used in ho... | Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 1, 2016 | Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radi... | Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 1, 2016 | Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile,... | Upon failure of the press-fit, the clamping sub components and pins could disassociate from the S... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 1, 2016 | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Str... | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fib... | Class II | Ethicon, Inc. |
| Aug 1, 2016 | Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture | There is a potential for the needle to detach from the suture thread during surgery. If the need... | Class II | Aesculap Implant Systems LLC |
| Aug 1, 2016 | Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion sy... | Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusi... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start... | Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) ... | Class II | B. Braun Medical, Inc. |
| Jul 29, 2016 | ROSA BRAIN 3.0.0 | Non-conforming product label. | Class II | Zimmer Biomet, Inc. |
| Jul 28, 2016 | Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Al... | The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that coul... | Class II | Alcon Research, Ltd. |
| Jul 28, 2016 | LAUREATE World Phaco System | Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) | Class II | Alcon Research, Ltd. |
| Jul 28, 2016 | Hospira MedNet Medication Management Suite software, version 6.1, List Number... | Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result... | Class II | Hospira Inc., A Pfizer Company |
| Jul 28, 2016 | Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML,... | A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a lo... | Class II | Handicare AB |
| Jul 28, 2016 | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product... | A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than ex... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| Jul 27, 2016 | CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's v... | A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time dat... | Class II | INNOKAS MEDICAL OY |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
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.