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 |
|---|---|---|---|---|
| Apr 12, 2013 | BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive di... | In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiologic... | Class II | Becton Dickinson & Co. |
| Apr 12, 2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... | Product coatings require 510K approval. | Class II | Progressive Medical Inc |
| Apr 12, 2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparo... | Product coatings require 510K approval. | Class II | Progressive Medical Inc |
| Apr 11, 2013 | KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HO... | Some joints on the doors of a limited number of IDA beds may loosen or separate over time which c... | Class II | mobility unlimited inc |
| Apr 11, 2013 | Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed D... | Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to... | Class II | Varian Medical Systems, Inc. |
| Apr 10, 2013 | The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybr... | GE Healthcare has recently become aware of an incident where the wrong part of the patient body w... | Class II | GE Healthcare, LLC |
| Apr 10, 2013 | LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE... | Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488... | Class II | Boston Scientific CRM Corp |
| Apr 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... | Class II | Philips Medical Systems, Inc. |
| Apr 10, 2013 | Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (... | There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. | Class II | Symmetry Medical/SSI |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, ... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, pa... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an in... | Several complaints were recorded regarding one of the three screws driving through the cage of th... | Class II | Ebi, Llc |
| Apr 9, 2013 | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is... | Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8... | Class II | Instrumentation Laboratory Co. |
| Apr 9, 2013 | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 i... | The incorrect manual may have been packaged with this product. UVB-080 devices may have included ... | Class III | National Biological Corp |
| 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 |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, ... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 9, 2013 | GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the fol... | GE Healthcare has recently become aware of a potential safety issue due to non-unique series iden... | Class II | GE Healthcare, LLC |
| Apr 9, 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, p... | Cartridges may contain individual discs which were not impregnated with antibiotic. | Class II | Remel Inc |
| Apr 8, 2013 | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is... | The incorrect manual may have been packaged with this product. UVB-083 devices may have included... | Class III | National Biological Corp |
| Apr 8, 2013 | Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product I... | Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... | Class II | Covidien LLC |
| Apr 8, 2013 | Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... | The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... | Class II | Ethicon Endo-Surgery Inc |
| Apr 8, 2013 | HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M,... | Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. | Class II | Philips Healthcare Inc. |
| Apr 8, 2013 | Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Produ... | Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could re... | Class II | Covidien LLC |
| Apr 5, 2013 | Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batterie... | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instrumen... | Class I | Newport Medical Instruments Inc |
| Apr 5, 2013 | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitativ... | Review of validation information and customer complaints which indicated preliminary screen posit... | Class II | Medtox Diagnostics Inc |
| Apr 4, 2013 | QuietCare-Networked. Intended for use in monitoring the environmental cond... | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Class II | Intel-GE Care Innovations LLC |
| Apr 4, 2013 | Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, im... | When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain ass... | Class II | Roche Diagnostics Operations, Inc. |
| Apr 4, 2013 | 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Cont... | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2... | Class II | B. Braun Medical, Inc. |
| Apr 4, 2013 | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Pr... | Internal investigation demonstrated under-recovery for glucose when tested against a reference me... | Class II | Polymer Technology Systems, Inc. |
| Apr 4, 2013 | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-... | The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislab... | Class II | Remel Inc |
| Apr 4, 2013 | LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060... | An LPC Fine Mesh Cassette failed to stay closed during processing operations. | Class II | Leica Microsystems, Inc. |
| Apr 4, 2013 | QuietCare. Intended for use in monitoring the environmental conditions and... | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Class II | Intel-GE Care Innovations LLC |
| Apr 4, 2013 | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic... | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Apr 4, 2013 | Software correction applies to customers who use the RT Therapist RTT4.2.108... | Software update to fix multiple safety related issues. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 4, 2013 | ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in t... | Expiration date on the patient label and date on the product carton were not the same. | Class II | Medshape Solutions, INC. |
| Apr 4, 2013 | Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of or... | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Apr 4, 2013 | 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Cont... | Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2... | Class II | B. Braun Medical, Inc. |
| Apr 3, 2013 | GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage... | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... | Class II | GE Healthcare, LLC |
| Apr 3, 2013 | TOSHIBA Kalare Diagnostic X-Ray System K110785 | Firm initiated recall because when radiographic conditions with the small focus are set and the r... | Class II | Toshiba American Medical Systems Inc |
| Apr 3, 2013 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Health... | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... | Class II | GE Healthcare, LLC |
| Apr 3, 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The int... | GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... | Class II | GE Healthcare, LLC |
| Apr 3, 2013 | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho... | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 de... | Class III | Ortho-Clinical Diagnostics |
| Apr 2, 2013 | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc.... | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors in... | Class II | Synvasive Technology Inc |
| Apr 1, 2013 | List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Bloo... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 In... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP;... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | 3DKnee e+ Tibial Insert. The insert is used along with the other components t... | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels... | Class II | Encore Medical, Lp |
| Apr 1, 2013 | List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, No... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE ... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Apr 1, 2013 | cobas¿ 4800 system z480 instrument. Integrates fully automated total nu... | In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.... | Class II | Roche Molecular 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.