Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 22, 2015 | Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use wit... | Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... | Class II | Siemens Healthcare Diagnostics Inc |
| Jan 22, 2015 | Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Ro... | When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outs... | Class II | Mako Surgical Corporation |
| Jan 22, 2015 | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3... | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of t... | Class II | Carl Zeiss Meditec AG |
| Jan 22, 2015 | MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. | Product may have separating or protruding sponges | Class II | Baxter Healthcare Corp. |
| Jan 22, 2015 | Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use wi... | Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... | Class II | Siemens Healthcare Diagnostics Inc |
| Jan 22, 2015 | GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered ... | The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex... | Class II | Zimmer Dental Inc |
| Jan 22, 2015 | Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For us... | Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... | Class II | Siemens Healthcare Diagnostics Inc |
| Jan 21, 2015 | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with th... | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... | Class II | Intuitive Surgical, Inc. |
| Jan 21, 2015 | Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Ma... | A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, result... | Class II | Merge Healthcare, Inc. |
| Jan 21, 2015 | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 2... | Drug products contained within the kits may have been rendered ineffective by a duplicate sterili... | Class II | Medical Components, Inc dba MedComp |
| Jan 21, 2015 | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 | A device malfunction may cause the biopsy needle to fail to reach the intended target. If locatio... | Class II | iCAD, Inc. |
| Jan 21, 2015 | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Pict... | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Modu... | Class II | TeraRecon, Inc. |
| Jan 21, 2015 | HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use ... | Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... | Class II | Intuitive Surgical, Inc. |
| Jan 21, 2015 | Siemens LANTIS Oncology Information System Servers; allows the radiation the... | There is a potential safety risk when using LANTIS server software with operating systems with wh... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 20, 2015 | Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for ... | A customer relayed a complaint of a leaking dialysis tubing connector. | Class II | Molded Products Inc |
| Jan 19, 2015 | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the... | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 16, 2015 | BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, ... | CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for ... | Class II | CME America, LLC |
| Jan 16, 2015 | KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr... | Defect: A hole or crack was found which may cause air to leak. | Class II | Halyard Health |
| Jan 16, 2015 | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system.... | The recommended sterilization and drying parameters are not effective to achieve the minimum requ... | Class II | Brainlab AG |
| Jan 16, 2015 | Artis One; The Artis One is an angiography system developed for diagnostic in... | The possibility exists that the monitor may fail and requires a power circle (shutdown and then p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 16, 2015 | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: ... | The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commerc... | Class I | HeartWare Inc |
| Jan 16, 2015 | KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... | Defect: A hole or crack was found which may cause air to leak. | Class II | Halyard Health |
| Jan 16, 2015 | KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Steril... | Defect: A hole or crack was found which may cause air to leak. | Class II | Halyard Health |
| Jan 15, 2015 | ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packagin... | On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering... | Class II | Advanced Medical Solutions Ltd. |
| Jan 15, 2015 | Bifircated Extension Set, Product Code: BN-828 Accessory device used to admi... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory devi... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Acce... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to admi... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Acc... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used ... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination o... | Complaints have been confirmed on failed proficiency testing due to serum samples recovering too ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jan 15, 2015 | da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 Sy... | The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inc... | Class II | Intuitive Surgical, Inc. |
| Jan 15, 2015 | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ... | There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Jan 15, 2015 | ViewRay System, Radiation Therapy System | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) ... | Class II | Viewray Incorporated |
| Jan 15, 2015 | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory devi... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device us... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary pa... | On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discoverin... | Class II | Advanced Medical Solutions Ltd. |
| Jan 15, 2015 | 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to admin... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 15, 2015 | 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV ... | Potential for leaking caused by insufficient bond between needleless device and female luer. | Class II | Churchill Medical Systems, Inc. |
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adapt... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adapto... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Ad... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier ... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
| Jan 14, 2015 | Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIF... | The packages may contain foreign material (black particles). | Class II | Teleflex Medical |
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.