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 |
|---|---|---|---|---|
| Jul 25, 2017 | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-... | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen cath... | Class II | Arrow International Inc |
| Jul 25, 2017 | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Commu... | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 24, 2017 | Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS111111102... | Implant kit mislabeled | Class II | ConforMIS, Inc. |
| Jul 24, 2017 | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cart... | Punch may have a burr in one section of the joint and when the punch is open, there is an increas... | Class II | Richard Wolf GmbH |
| Jul 24, 2017 | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implan... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit C... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, M... | Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the ... | Class II | X-Laser Llc |
| Jul 24, 2017 | NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral ... | There is a possibility that the protective foam insert used during the packaging of the affected ... | Class II | ZIMMER ORTHOPEDIC MFG LTD |
| Jul 24, 2017 | Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implant... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgu... | The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after mu... | Class II | Smith & Nephew, Inc. |
| Jul 24, 2017 | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implanta... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implant... | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillator... | Class II | Sorin Group Italia SRL - CRF |
| Jul 24, 2017 | 3-Way Standardbore Stopcock. Product Code: AMS-100. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic H... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plas... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 22, 2017 | QIAamp DSP Virus Kit Cat. No. 60704 | Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in... | Class II | Qiagen, GmbH |
| Jul 21, 2017 | Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, ... | Inner and outer sterile barriers not fully sealed. | Class II | Howmedica Osteonics Corp. |
| Jul 21, 2017 | FUJINON ED-530XT. This device is intended for the visualization of the duo... | An update to the design and labeling was implemented to help reduce patient risk associated with ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jul 21, 2017 | Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 | Inner and outer sterile barriers not fully sealed. | Class II | Howmedica Osteonics Corp. |
| Jul 21, 2017 | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th... | The plates do not have wells punched for the controls in the patient 1 area. | Class II | Helena Laboratories, Corp. |
| Jul 21, 2017 | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9... | A component in the Certitude Loader may have a molding overflow defect that could detach during ... | Class I | Edwards Lifesciences, LLC |
| Jul 21, 2017 | MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-P... | It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity... | Class II | Stryker Medical Division of Stryker Corporation |
| Jul 21, 2017 | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | The locking mechanism and protective cap were missing from the sterile packed nails of the affect... | Class II | Synthes (USA) Products LLC |
| Jul 21, 2017 | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, ... | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jul 20, 2017 | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The fi... | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely ... | Class II | Beckman Coulter Inc. |
| Jul 19, 2017 | GENICON EZEE Retrieval, sterile, Rx only. | Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. | Class II | Genicon, Inc. |
| Jul 19, 2017 | Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm ... | For some of the recalled products, the security of the connection between the shaft and the tool ... | Class II | Teleflex Medical |
| Jul 19, 2017 | Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm atta... | For some of the recalled products, the security of the connection between the shaft and the tool ... | Class II | Teleflex Medical |
| Jul 19, 2017 | Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5m... | For some of the recalled products, the security of the connection between the shaft and the tool ... | Class II | Teleflex Medical |
| Jul 19, 2017 | Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments... | For some of the recalled products, the security of the connection between the shaft and the tool ... | Class II | Teleflex Medical |
| Jul 19, 2017 | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY... | The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots... | Class II | Kamiya Biomedical Company, LLC |
| Jul 19, 2017 | Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5... | For some of the recalled products, the security of the connection between the shaft and the tool ... | Class II | Teleflex Medical |
| Jul 19, 2017 | Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System wit... | For some of the recalled products, the security of the connection between the shaft and the tool ... | Class II | Teleflex Medical |
| Jul 18, 2017 | cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 ... | A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series ... | Class II | Roche Diagnostics Corporation |
| Jul 18, 2017 | cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 ... | A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODU... | Class II | Roche Diagnostics Corporation |
| Jul 18, 2017 | BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for colle... | BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and i... | Class II | Becton Dickinson & Co. |
| Jul 18, 2017 | BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collecti... | BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and i... | Class II | Becton Dickinson & Co. |
| Jul 18, 2017 | BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for col... | BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and i... | Class II | Becton Dickinson & Co. |
| Jul 18, 2017 | AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE ... | Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect... | Class II | Vyaire Medical |
| Jul 18, 2017 | Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek pla... | Product did not undergo correct sterilization procedures and may potentially be non-sterile. | Class II | Medline Industries Inc |
| Jul 17, 2017 | RayStation Product Usage: is a software system designed for treatment pl... | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout positi... | Class II | RAYSEARCH LABORATORIES AB |
| Jul 17, 2017 | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
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.