Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 23, 2014 | Symbia E camera system. Emission Computed Tomography System used to detect o... | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 23, 2014 | Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... | CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... | Class I | CareFusion 303, Inc. |
| Apr 23, 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using S... | Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 23, 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasoun... | Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 23, 2014 | Synergy XVI Intended for radiation therapy treatment. | XVI can incorrectly calculate the target position of the treatment table. | Class II | Elekta, Inc. |
| Apr 23, 2014 | GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w ... | GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products.... | Class II | GE Healthcare, LLC |
| Apr 23, 2014 | e.cam camera system. Emission Computed Tomography System used to detect or i... | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 23, 2014 | Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone ge... | William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or clea... | Class II | William C. Domb, D.M.D., A Professional Corpora... |
| Apr 23, 2014 | Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Sutu... | CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absor... | Class II | C P Medical Inc. |
| Apr 23, 2014 | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 med... | The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the ... | Class II | Heraeus Kulzer, LLC. |
| Apr 22, 2014 | ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesi... | This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge r... | Class II | Biomet, Inc. |
| Apr 22, 2014 | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Sh... | It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter ... | Class II | Synthes, Inc. |
| Apr 22, 2014 | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 ... | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a res... | Class II | Meridian Bioscience Inc |
| Apr 22, 2014 | UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrate... | Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron ... | Class II | Beckman Coulter Inc. |
| Apr 22, 2014 | HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anes... | Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the ac... | Class I | Hamilton Medical, Inc. |
| Apr 22, 2014 | SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with t... | The hose could separate from the blanket. | Class II | Smiths Medical ASD, Inc. |
| Apr 21, 2014 | Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile. | Out of specification results for one of the two disinfectants. | Class II | Bausch & Lomb Inc- Greenville Solutions Plant |
| Apr 21, 2014 | Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt ... | AIC (USA) received information regarding 3 complaints in which the deflector did not move freely ... | Class II | Aesculap, Inc. |
| Apr 18, 2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ..... | All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have ... | Class II | Med-Mizer, Inc. |
| Apr 18, 2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803,... | All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have... | Class II | Med-Mizer, Inc. |
| Apr 18, 2014 | Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t... | Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry d... | Class II | Leica Microsystems, Inc. |
| Apr 18, 2014 | Recalled product is a component of the Newport Medical Instruments e360 Vent... | Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilat... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Apr 18, 2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed... | All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have ... | Class II | Med-Mizer, Inc. |
| Apr 17, 2014 | The Patient Control Module (PCM) is used in conjunction with a Baxter infusor... | Potential for device malfunction resulting in flow when the device should not be flowing | Class II | Baxter Healthcare Corp. |
| Apr 17, 2014 | McKesson Radiology-PACS. McKesson Radiology is a medical image and informa... | High priority alert icon was not displayed in the Study List when there are no Stat studies prese... | Class II | Mckesson Medical Immaging |
| Apr 17, 2014 | HexaPOD evo RT Couchtop. To support and aid in positioning a patient durin... | If screws are not properly tightened with a torque wrench they may become loose over time. | Class II | Elekta, Inc. |
| Apr 17, 2014 | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed usi... | Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an ele... | Class II | Nanosphere, Inc. |
| Apr 17, 2014 | enGen (TM) Laboratory Automation System Configured with TCAutomation" Softwar... | Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Sys... | Class II | Ortho-Clinical Diagnostics |
| Apr 17, 2014 | Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RC... | Product is being recalled due to complaints that the inspiratory and expiratory tubes are transpo... | Class II | Teleflex Medical |
| Apr 17, 2014 | APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233... | Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collectio... | Class III | Gen-Probe Inc |
| Apr 16, 2014 | RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF... | Possible breach in sterile barrier for inner and outer bags of the product. | Class II | Baxter Corporation Englewood |
| Apr 16, 2014 | Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Al... | Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or nea... | Class I | Alere San Diego, Inc. |
| Apr 16, 2014 | DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies an... | DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction Syste... | Class I | Synthes, Inc. |
| Apr 16, 2014 | Maquet PowerLED 700. Product Usage; To provide illumination to the surgi... | Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or sev... | Class II | Maquet Medical Systems USA |
| Apr 16, 2014 | Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemi... | This Lot has variations in melting temperature. | Class II | Sakura Finetek USA Inc |
| Apr 16, 2014 | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Pr... | The firm received several complaints for internal blood leaks involving various lot numbers produ... | Class II | Gambro Renal Products, Incorporated |
| Apr 16, 2014 | Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Ren... | The firm received several complaints for internal blood leaks involving various lot numbers produ... | Class II | Gambro Renal Products, Incorporated |
| Apr 16, 2014 | Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use wi... | Integra LifeSciences has identified through a small number of complaints that some lot numbers of... | Class II | Integra LifeSciences Corp. |
| Apr 16, 2014 | 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray i... | Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide d... | Class II | Stryker Endoscopy |
| Apr 16, 2014 | HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Heart... | Patients and caregivers are instructed that if a battery does not provide two hours of support or... | Class II | HeartWare Inc |
| Apr 15, 2014 | ExacTrac 5.5, an Image Processing System used for patient positioning for rad... | When using a specific plan update workflow in combination with a non-Brainlab treatment planning ... | Class II | Brainlab AG |
| Apr 15, 2014 | Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP... | The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is like... | Class I | Fisher & Paykel Healthcare, Ltd. |
| Apr 15, 2014 | EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthope... | The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... | Class II | Biomet, Inc. |
| Apr 15, 2014 | EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunc... | The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... | Class II | Biomet, Inc. |
| Apr 15, 2014 | RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patient... | Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the h... | Class II | Cordis Corporation |
| Apr 15, 2014 | ReTurn 7500/7500 Aid, transfer | During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw an... | Class II | Handicare USA, Inc. |
| Apr 15, 2014 | EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manu... | The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... | Class II | Biomet, Inc. |
| Apr 14, 2014 | Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with... | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 14, 2014 | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introdu... | Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted... | Class II | Arrow International Inc |
| Apr 14, 2014 | Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Ti... | Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm... | Class II | Merit Medical Systems, 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.