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 |
|---|---|---|---|---|
| May 6, 2015 | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (... | IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to s... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 6, 2015 | R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| May 6, 2015 | D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA ... | Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. | Class III | Biocare Medical, LLC |
| May 6, 2015 | The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing ... | D50 and D51 diagnostic error codes are not functional. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 6, 2015 | R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| May 5, 2015 | Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Pa... | Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. | Class II | Medtronic Navigation, Inc. |
| May 5, 2015 | Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ra... | under certain circumstances the Cios Alpha system may freeze during a procedure. | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2015 | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | The Astral device allows clinicians to disable all alarms including those that detect circuit dis... | Class II | ResMed Ltd. |
| May 5, 2015 | Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number I... | Potential device damage on the strain relief near the hub area, which may result in blood leakage. | Class II | Edwards Lifesciences, LLC |
| May 5, 2015 | ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression,... | potential safety risk of collision of the LINAC gantry with the patient or the treatment table i... | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2015 | Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. F... | The product failed to meet the internal established statistical test requirement for heparin acti... | Class II | Edwards Lifesciences, LLC |
| May 4, 2015 | Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per ... | Product may be contaminated with Listeria monocytogenes. | Class II | Remel Inc |
| May 4, 2015 | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhyt... | Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 28... | Class II | Spine Wave, Inc. |
| May 4, 2015 | GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). | The heart rate could be calculated from pacer pulses without indication that pacemaker detection ... | Class II | GE Healthcare |
| May 4, 2015 | Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID P... | Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Se... | Class II | Smiths Medical Asd Inc |
| May 4, 2015 | Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103... | Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm becaus... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 2, 2015 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e,... | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1... | Class II | Neusoft Medical Systems Co., Ltd. |
| May 2, 2015 | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... | Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch du... | Class I | Synovis Surgical Innovations, Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled St... | The firm discovered an improperly installed set screw in one caster arm assembly on a unit in pro... | Class II | Ferno-Washington Inc |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Pe... | Terumo CVS is implementing field correction activities to address the identified causes of the Te... | Class II | Terumo Cardiovascular Systems Corporation |
| May 1, 2015 | Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Pe... | Terumo CVS is implementing field correction activities to address the identified causes of the Te... | Class II | Terumo Cardiovascular Systems Corporation |
| May 1, 2015 | Unilateral external fixation ankle clamp Product Usage: Unilateral extern... | Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. Thi... | Class II | Biomet, Inc. |
| May 1, 2015 | Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... | Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Nee... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Apr 30, 2015 | I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display... | complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. | Class II | Neuro Kinetics, Inc. |
| Apr 30, 2015 | PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual ... | Potential for uncured adhesive between the metal threaded insert and the impactor block to leak o... | Class II | Zimmer, Inc. |
| Apr 30, 2015 | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intend... | Sterility of device maybe compromised | Class II | Smith & Nephew, Inc. |
| Apr 29, 2015 | LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care setti... | The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will... | Class II | LifeHealth, LLC |
| Apr 29, 2015 | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquef... | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... | Class II | Richard-Allan Scientific Company |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ... | Failures of the splice repair kit if exposed to excessive force. | Class I | HeartWare Inc |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tr... | Complaints with the HVAD Abnormal Power Source Switching. | Class II | HeartWare Inc |
| Apr 29, 2015 | Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Muco... | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... | Class II | Richard-Allan Scientific Company |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... | Complaints with the HVAD Internal Controller Alarm Battery failures. | Class I | HeartWare Inc |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / ... | HeartWare has received complaints relating to damage or bent connection pins within the power sup... | Class I | HeartWare Inc |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 110... | Complaints with the HVAD Retraction of Pins within the driveline connector. | Class I | HeartWare Inc |
| Apr 29, 2015 | Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail... | The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compat... | Class II | Zimmer, Inc. |
| Apr 29, 2015 | Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glov... | Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufa... | Class II | Centurion Medical Products Corporation |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tra... | Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. | Class II | HeartWare Inc |
| Apr 29, 2015 | EasyLink Data Management System; a clinical data management system that assis... | System Limitations and Software Issues related to the following features: Custom reference range... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 28, 2015 | VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vasc... | Possible sterility breach of the outer packaging (pouch) material which may compromise the outsid... | Class II | Covidien LLC |
| Apr 28, 2015 | The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use... | The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves d... | Class II | Alcon Research, Ltd. |
| Apr 28, 2015 | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product U... | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's ... | Class III | Acclarent, Inc. |
| Apr 27, 2015 | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ... | Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or... | Class II | DeRoyal Industries Inc |
| Apr 27, 2015 | 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, ... | Incorrect expiration date on label | Class II | MRP, LLC dba AMUSA |
| Apr 27, 2015 | Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter persona... | Recovery of high count of gram positive rods including single colonies of B. cepacia. | Class II | Sheffield Pharmaceuticals, LLC |
| Apr 27, 2015 | Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon C... | One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrec... | Class II | Boston Scientific Corporation |
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.