Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 14, 2013 | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserter... | Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fal... | Class II | SpineFrontier, Inc. |
| Mar 14, 2013 | The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For... | Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect ... | Class II | Synvasive Technology Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells... | Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to Ja... | Class II | Separation Technology, Inc. |
| Mar 13, 2013 | Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories... | Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable conn... | Class II | Masimo Corporation |
| Mar 13, 2013 | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing... | This recall is being initiated because the affected lots of this product may yield results that a... | Class II | Epocal |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For ... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For... | Negative bias in patient samples for Vitamin D | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 13, 2013 | Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W... | Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 in... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 13, 2013 | Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. ... | Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Sti... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 12, 2013 | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepa... | Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector w... | Class II | Bio-Detek, Inc. |
| Mar 12, 2013 | Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls... | The firm received complaints for unintended movements. | Class II | Berchtold Corp. |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare has become aware of a potential safety issue associated with the use of GE Centrici... | Class II | GE Healthcare It |
| Mar 12, 2013 | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. | Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were n... | Class II | Custom Ultrasonics, Inc. |
| Mar 12, 2013 | Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Wat... | Philips Healthcare received a report from the field stating when they viewed the CTDIVol informat... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instr... | Class II | GE Healthcare It |
| Mar 11, 2013 | Centricity Perinatal and Centricity Intensive Care is intended to be used in ... | 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count ... | Class II | GE Healthcare It |
| Mar 11, 2013 | Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination o... | Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 11, 2013 | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - M... | The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead o... | Class I | Lifescan Inc |
| Mar 11, 2013 | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog N... | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as ... | Class II | Keystone Dental Inc |
| Mar 11, 2013 | BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing m... | Microbiological media may be contaminated with bacteria. | Class II | Becton Dickinson & Co. |
| Mar 11, 2013 | BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms. | Microbiological media may be contaminated with bacteria. | Class II | Becton Dickinson & Co. |
| Mar 11, 2013 | BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate... | Microbiological media may be contaminated with bacteria. | Class II | Becton Dickinson & Co. |
| Mar 8, 2013 | LifeCare PCA infusion system with Hospira MedNet software allows clinicians t... | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... | Class II | Hospira Inc. |
| Mar 8, 2013 | The LifeCare Pump Model 4200 PCA Infuser makes possible the practical impleme... | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... | Class II | Hospira Inc. |
| Mar 8, 2013 | The PCA 3 system cam be used in a wide range of clinical settings, including ... | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... | Class II | Hospira Inc. |
| Mar 8, 2013 | The LifeCare PCA Plus II infusion pump system is designed for safe, effective... | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... | Class II | Hospira Inc. |
| Mar 8, 2013 | LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Nu... | Screw rotation error occurring when the pump detects a mismatch between the number of steps given... | Class II | Hospira Inc. |
| Mar 8, 2013 | APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas L... | Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing an... | Class II | Spinal Solutions, LLC |
| Mar 8, 2013 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, ... | A post market safety review following several customer complaints indicated additional clarificat... | Class II | Synthes USA HQ, Inc. |
| Mar 8, 2013 | MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen deli... | A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs. | Class II | Linde Gas North America Llc |
| Mar 8, 2013 | Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal ... | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled wi... | Class II | Synthes USA HQ, Inc. |
| Mar 8, 2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a p... | Class II | Ormco/Sybronendo |
| Mar 8, 2013 | LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administ... | Screw rotation error occurring when the pump detects a mismatch between the number of steps given... | Class II | Hospira Inc. |
| Mar 8, 2013 | Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license i... | The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC2... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2013 | Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BG... | Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold sys... | Class II | Orthopedic Alliance LLC |
| Mar 7, 2013 | Torrent" irrigation tubing. Product Usage: The Torrent irrigation sys... | The firm was notified by their customers that there was a water leakage from the white tubing con... | Class II | US Endoscopy Group Inc |
| Mar 7, 2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 8... | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter c... | Class II | DeVilbiss Healthcare LLC |
| Mar 7, 2013 | MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0... | It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown... | Class II | Maquet Cardiovascular, LLC |
| Mar 7, 2013 | Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator s... | When using the SERVO-i on battery power, in a very small number of cases, some battery modules di... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Mar 6, 2013 | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-20... | Customer complaint investigation confirmed the issue of false skipped wells and false susceptible... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 6, 2013 | KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm)... | Some individual container filter units might contain thin areas that may potentially compromise t... | Class II | Kimberly-Clark Corporation |
| Mar 6, 2013 | GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade ... | Incorrect blue/white suture was used. | Class II | Linvatec Corp. dba ConMed Linvatec |
| Mar 6, 2013 | The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Ca... | The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to ... | Class II | Alere San Diego, Inc. |
| Mar 6, 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The... | The recall was initiated because Carefusion has identified potential risk associated with bolus p... | Class II | Carefusion Corporation |
| Mar 6, 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The A... | The recall was initiated because Carefusion has received reports of a communication error on the ... | Class I | Carefusion Corporation |
| Mar 6, 2013 | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitr... | The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT A... | Class II | Alere San Diego, Inc. |
| Mar 6, 2013 | ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Use... | Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 6, 2013 | Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by ... | Unapproved medical device | Class II | Advanced Orthogonal Equipment, Incorporated |
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.