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 |
|---|---|---|---|---|
| Mar 13, 2015 | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950... | IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypers... | Class II | Bard Peripheral Vascular Inc |
| Mar 13, 2015 | Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus ... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile dev... | A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 w... | Class II | Integra LifeSciences Corp. |
| Mar 13, 2015 | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotra... | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... | Class II | Vital Signs Colorado Inc. |
| Mar 13, 2015 | Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, AD... | During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 13, 2015 | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container ... | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen ... | Class III | Pointe Scientific, Inc. |
| Mar 13, 2015 | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Co... | Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant siz... | Class II | Teleflex Medical |
| Mar 13, 2015 | Ebola Accessories assembled, self-contained package, Catalog No. I-104 vir... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials P... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. ... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc... | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum F... | Class II | Bard Access Systems |
| Mar 13, 2015 | Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Mater... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Introduction Pack. A device inserted into an endotracheal tube to aid in the... | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... | Class II | Vital Signs Colorado Inc. |
| Mar 13, 2015 | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. T... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 13, 2015 | Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials P... | LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... | Class I | Lusys Laboratories, Inc. |
| Mar 12, 2015 | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxia... | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression te... | Class II | Biomet Spine, LLC |
| Mar 12, 2015 | GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate ... | GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of... | Class II | GE Healthcare |
| Mar 12, 2015 | Alaris PC units, Model No. 8015. Infusion pump. | CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur up... | Class II | CareFusion 303, Inc. |
| Mar 12, 2015 | Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usa... | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/... | Class II | Biomet Spine, LLC |
| Mar 12, 2015 | Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A... | Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is ... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Mar 12, 2015 | Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Us... | Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/... | Class II | Biomet Spine, LLC |
| Mar 11, 2015 | ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and ... | Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties. | Class I | Hummingbird Med |
| Mar 11, 2015 | Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imagin... | It was noticed that the spectroscopy voxel map did not align with the anatomical images of the ph... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 11, 2015 | INFX-8000V Interventional Angiography System. CAT-880B catheterization table... | The table base rotational brake that holds the table top may not always be engaged when any force... | Class II | Toshiba American Medical Systems Inc |
| Mar 11, 2015 | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation devi... | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x... | Class II | X Spine Systems Inc |
| Mar 11, 2015 | Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC ... | The firm was notified by a customer that the collimator exchange carriage and the collimator stor... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 10, 2015 | LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QT... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, R... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Numb... | Software Anomaly; It is possible for the device to process samples with a cartridge other than th... | Class II | Ortho-Clinical Diagnostics |
| Mar 10, 2015 | Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Person... | Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking ... | Class II | Zimmer, Inc. |
| Mar 10, 2015 | LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK -... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO I... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign b... | A wire component on the distal grasping assembly of the device became detached.. | Class II | US Endoscopy Group Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE,... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Ste... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERIL... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 9, 2015 | Fujifilm Endoscope Model ED-530XT Product Usage: This product is a me... | Fujifilm is reporting a corrective action due to an FDA inspection. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalan... | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated... | Class II | In2Bones, SAS |
| Mar 9, 2015 | NobelReplace CC RP 5.0x8mm, Article No. 36710. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Compon... | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... | Class II | Specialty Appliance Works, 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.