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 |
|---|---|---|---|---|
| Nov 3, 2017 | Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Produc... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Pr... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Pro... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hema... | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | Handicare P600 Series Patient Lift Product Usage: A device used to lift and... | Premature strap wear and breakage at maximum weight conditions (625 lbs.). | Class II | Handicare Usa Inc |
| Nov 3, 2017 | Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) R... | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during us... | Class II | Volcano Corporation |
| Nov 3, 2017 | Handicare C Series Patient Lift Product Usage: A device used to lift and ... | Premature strap wear and breakage at maximum weight conditions (625 lbs.). | Class II | Handicare Usa Inc |
| Nov 3, 2017 | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten... | Stent length on the label may not match the length of the stent itself. | Class II | Medtronic Inc. |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 462... | Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly a... | Class II | Brainlab AG |
| Nov 3, 2017 | bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 ... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: ... | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-c... | Affected lots may have exceeded its microbial limits. | Class II | Madison Polymeric Engineering |
| Nov 3, 2017 | NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 2, 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected U... | There is a potential for leaking vials for certain lot numbers where, if proper attire is not use... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 2, 2017 | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Product may have incorrect cation information detailed on the product label. | Class II | Remel Inc |
| Nov 2, 2017 | pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 ... | The firm received reports of two breakages of the pin tips which occurred during two identical su... | Class II | Pro-Med Instruments Gmbh |
| Nov 2, 2017 | Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysi... | The diagnostic test kit may produce invalid test runs which may delay test results. | Class II | Epigenomics Ag |
| Nov 1, 2017 | ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811... | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised steril... | Class II | Microline Surgical, Inc. |
| Nov 1, 2017 | ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 008110990121... | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised steril... | Class II | Microline Surgical, Inc. |
| Nov 1, 2017 | ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014... | Mold was found on the non-patient contact surfaces of the product and was identified as Aspergi... | Class II | 3M Company - Health Care Business |
| Nov 1, 2017 | Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Ther... | The internal configuration of the electrometers and the Real-Time control boards of the Dekimo S... | Class II | Ion Beam Applications S.A. |
| Nov 1, 2017 | Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) ... | One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 30, 2017 | VariCam | A potential hazardous situation may occur if the collimator locking handle is not properly placed... | Class II | GE Healthcare, LLC |
| Oct 30, 2017 | Plum 360 Infusion System, List number 30010. | (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" sta... | Class II | ICU Medical Inc |
| Oct 30, 2017 | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Nu... | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggybac... | Class II | ICU Medical Inc |
| Oct 30, 2017 | Discover VH/Millennium VG Nuclear Medicine Imaging System | A potential hazardous situation may occur if the collimator locking handle is not properly placed... | Class II | GE Healthcare, LLC |
| Oct 30, 2017 | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the... | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after... | Class II | Sorin Group Deutschland GmbH |
| Oct 29, 2017 | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use... | It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the f... | Class III | Xintec Corp |
| Oct 28, 2017 | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows aud... | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat... | Class II | NordicNeuroLab AS |
| Oct 27, 2017 | LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-00... | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing... | Class I | Physio-Control, Inc. |
| Oct 27, 2017 | L3 Security & Detection System Cabinet X-ray system used for security screeni... | L3 has determined in airport environments, there have been several cases where a small air gap ha... | Class II | L3 Security & Detection |
| Oct 27, 2017 | LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 ... | The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing... | Class I | Physio-Control, Inc. |
| Oct 27, 2017 | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes.... | The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for... | Class II | Roche Molecular Systems, Inc. |
| Oct 26, 2017 | Arterial Access Tray, introducer catheter; Model: GU-04020 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04020-C | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04120 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International Inc |
| Oct 26, 2017 | Radial Artery Catheterization Kit; Model: AK-04018 | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... | Class II | Arrow International 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.