Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 24, 2013 | S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. ... | Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegi... | Class II | Sorin Group Deutschland GmbH |
| Sep 23, 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... | Class I | Baylis Medical Corp * |
| Sep 18, 2013 | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus... | GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires ... | Class II | GE Healthcare Beijing , Hangwei Medical Systems... |
| Sep 4, 2013 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calc... | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens r... | Class II | SEPPIM SAS |
| Aug 9, 2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... | The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... | Class III | Copan Italia |
| Aug 5, 2013 | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended ... | The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that... | Class II | Medicel Ag |
| Jul 25, 2013 | HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, He... | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Mi... | Class II | HemoCue AB |
| Jul 16, 2013 | HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, ... | HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Al... | Class II | HemoCue AB |
| Jul 15, 2013 | HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. ... | During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack ... | Class II | HemoCue AB |
| Jul 3, 2013 | Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Pai... | Lancets were not sterilized within the dose range established by sterilization validation. | Class II | KooJoo Trading Company |
| Jun 21, 2013 | MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or e... | Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue asso... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Jun 20, 2013 | TDHistology/Cytology Classification name: Calculator/data processing modul... | A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... | Class III | Technidata S.A. |
| Jun 7, 2013 | Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... | Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer... | Class II | Del Mar Reynolds Medical, Ltd. |
| May 23, 2013 | Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt ... | Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Sw... | Class II | Etac Supply Center Ab |
| May 14, 2013 | Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liqui... | It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks li... | Class II | Penlon, Ltd. |
| May 10, 2013 | 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 ... | MedCare Products has determined that a number of their Floor Lifts manufactured from 9/1/2010 to ... | Class II | ErgoSafe Product LLC dba Prism Medical Services |
| Apr 22, 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... | Software Error: The effect of setup on overall navigation accuracy could potentially intensify sm... | Class I | Brainlab AG |
| Apr 22, 2013 | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). ... | Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power ... | Class II | Fisher & Paykel Healthcare, Ltd. |
| Apr 17, 2013 | The Constellation Vision System Pneumatic Handpiece. Indicated for both an... | Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, prod... | Class II | Alcon Grieshaber AG |
| Apr 17, 2013 | VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrum... | Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefor... | Class II | BioMerieux SA |
| Apr 9, 2013 | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103... | Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the ... | Class II | Alpine Biomed Aps |
| Mar 20, 2013 | REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found i... | Investigation of complaints found excessive use of the instrument could result in cracking on the... | Class II | Biomet U.K., Ltd. |
| Feb 15, 2013 | Molift Smart 150 | The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. | Class II | Moller Vital |
| Feb 15, 2013 | Molift Smart 150 | The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user. | Class II | Moller Vital |
| Feb 15, 2013 | RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0... | Under some circumstances, imported CT, MR and PET images are offset from their true positions by ... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 15, 2013 | Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Worksta... | A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may caus... | Class I | Del Mar Reynolds Medical, Ltd. |
| Dec 21, 2012 | nordicBrainEX Product Usage: nordicBrainEx is an image processing softwar... | There is an error related to the relative geometry between fiber tracts in a fiber group and imag... | Class II | NordicNeuroLab AS |
| Dec 18, 2012 | Surgical microscope The device is used to improve the visibility of object... | The brake in the Z axis and/or brakes in the AB and C axes failed during installation. | Class II | Leica Microsystems (Schweiz) Ag |
| Dec 18, 2012 | Surgical microscope The device is used to improve the visibility of object... | The brake in the Z axis and/or brakes in the AB and C axes failed during installation. | Class II | Leica Microsystems (Schweiz) Ag |
| Dec 5, 2012 | Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product ... | Canon Inc. had received 17 claims from our foreign sales companies between October to November ... | Class II | Canon Inc. |
| Nov 19, 2012 | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing ... | FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes... | Class I | Fisher & Paykel Healthcare, Ltd. |
| Nov 7, 2012 | Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Trea... | Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... | Class II | Quanta System, S.p.A. |
| Nov 7, 2012 | Analyzing system consists of a small and portable analyzer and plastic microc... | Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made fro... | Class III | HemoCue AB |
| Nov 7, 2012 | Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument... | Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... | Class II | Quanta System, S.p.A. |
| Nov 7, 2012 | Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hai... | Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... | Class II | Quanta System, S.p.A. |
| Nov 7, 2012 | 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hyd... | Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report... | Class II | IDS (Immunodiagnostic Systems Ltd.) |
| Nov 5, 2012 | SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane... | A manufacturing defect was observed for the membrane changer insert that does not allow electroly... | Class II | Sentec AG |
| Nov 5, 2012 | SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign ... | A manufacturing defect was observed for the membrane changer insert that does not allow electroly... | Class II | Sentec AG |
| Nov 1, 2012 | Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I ... | APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect bar... | Class II | Abbott Point of Care Canada Limited |
| Oct 18, 2012 | NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz D... | The four screws that secure the patient table top to the carrier pulled out and caused the table ... | Class II | Philips And Neusoft Medical Systems Co., Ltd. |
| Sep 26, 2012 | DeGotzen XRay unit XGenus Dental X-ray unit. | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certi... | Class II | DeGotzen |
| Sep 13, 2012 | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to... | Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions tha... | Class I | Heartsine Technologies, Limited |
| Aug 10, 2012 | IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Pac... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 10, 2012 | IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box conta... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 10, 2012 | IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Bo... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 10, 2012 | MyRay RXDC dental unit x-ray unit | The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30... | Class II | CEFLA DENTAL GROUP |
| Aug 10, 2012 | IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboa... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 10, 2012 | IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number ... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 10, 2012 | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
| Aug 10, 2012 | IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Bo... | It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... | Class II | Immunodiagnostics Systems Ltd |
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.