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 |
|---|---|---|---|---|
| Feb 23, 2016 | Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... | Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... | Class II | Medtronic Inc. |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | QUADROX-i oxygenators Custom tubing packs for the oxygenator | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Feb 23, 2016 | Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Bl... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), ... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | cobas p 512 pre-analytical system Pre-analytical sample handling that incl... | Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not ... | Class II | Roche Diagnostics Operations, Inc. |
| Feb 23, 2016 | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons spec... | Potential disassociation of the orientation pin. | Class II | Mako Surgical Corporation |
| Feb 23, 2016 | Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiv... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 23, 2016 | Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Rec... | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or a... | Class I | Dexcom Inc |
| Feb 22, 2016 | Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#:... | Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the pac... | Class II | Innovative Ophthalmic Products, Inc |
| Feb 22, 2016 | BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile i... | Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed ... | Class II | Medtronic Navigation, Inc. |
| Feb 22, 2016 | Video Duodenoscope | Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a... | Class II | Pentax Medical Company |
| Feb 19, 2016 | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are di... | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... | Class II | Horiba Instruments Inc |
| Feb 19, 2016 | Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, ... | Customer complaints of very weak reactions with the kit, or false negative results with different... | Class II | Integrated Science Systems Inc |
| Feb 19, 2016 | Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discr... | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (ve... | Class II | Horiba Instruments Inc |
| Feb 19, 2016 | Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routi... | 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 19, 2016 | AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic i... | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. T... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2016 | CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... | Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... | Class II | Medtronic MiniMed Inc. |
| Feb 19, 2016 | Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of rout... | 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 19, 2016 | Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnost... | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. T... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2016 | Cios Alpha, mobile X-ray system | Software issues on Cios Alpha mobile C-Arm system | Class II | Siemens Medical Solutions USA, Inc |
| Feb 19, 2016 | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine ra... | 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 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 | ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diag... | Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA i... | Class II | TEM Systems Inc |
| Feb 18, 2016 | AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM A... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| 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 18, 2016 | The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Ov... | The instructional insert for the In Touch Control Solution for use with the In Touch meter and I... | Class II | Livongo Health |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique ... | When testing was conducted using certain lots, VITROS¿ Systems generated results within the measu... | Class II | Ortho-Clinical Diagnostics |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM A... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 18, 2016 | McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 1... | McKesson has identified a design deficiency where under rare circumstances, imported images/studi... | Class II | Mckesson Medical Immaging |
| Feb 18, 2016 | Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis z... | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. L... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 17, 2016 | TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STA... | The firm received a complaint of an open pouch which breaches the sterilization validation. | Class II | Applied Medical Technology Inc |
| 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 | Wilson Implantation System Product Usage: Indicated to aid in tissue retr... | The firm received a complaint of an open pouch which breaches the sterilization validation. | Class II | Applied Medical Technology Inc |
| Feb 17, 2016 | ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and... | The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheat... | Class II | Argon Medical Devices, Inc |
| Feb 17, 2016 | GE Healthcare, Aisys Carestation. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 17, 2016 | Acorn 180 Curved Stairlift | Aluminum rivets holding the base squab to the framer under prolonged customer use were seen to el... | Class II | Acorn Stairlifts 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.