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 1, 2013 | List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Conver... | 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 | VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 680... | The firm is recalling the specific lot due to lower than expected results. | Class II | Ortho-Clinical Diagnostics |
| Apr 1, 2013 | List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection S... | 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. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-... | 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 | 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an o... | Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, ... | Class II | Fresenius Medical Care Holdings, Inc. dba Renal... |
| Apr 1, 2013 | List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood... | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets t... | Class I | Hospira Inc. |
| Mar 31, 2013 | The UF-1000i is a fully automated urine particle analyzer intended for vitro ... | The current Century Break patch did not contain the same setting for the Century Break year for b... | Class II | Sysmex America, Inc. |
| Mar 30, 2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a s... | The recall has been initiated due to an overheating protection voltage suppressor on the redundan... | Class II | American Optisurgical Inc |
| Mar 29, 2013 | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466... | Correction to provide clarification and additional labeling to minimize likelihood on implanting ... | Class I | Cordis Corporation |
| Mar 28, 2013 | Integrity 1.1. Integrity is the interface and control software for the Ele... | The problem is that the "static tolerances" from the calibration files (loaded database) are used... | Class II | Elekta, Inc. |
| Mar 28, 2013 | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... | 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... | Class III | Abbott Molecular |
| Mar 28, 2013 | Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in sur... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product Code... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorb... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile uri... | Sterile packaging may be compromised. | Class II | Teleflex Medical |
| Mar 28, 2013 | Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absor... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recomm... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx... | On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were foun... | Class II | Custom Spine, Inc. |
| Mar 28, 2013 | Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regene... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB6... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matri... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbab... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant f... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorb... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasou... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only,... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | Absorbable Collagen Sponge Provided As Intermediate to Another Company | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that ... | When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be ... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 28, 2013 | NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of perip... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product C... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the m... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV... | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. | Class II | Transonic Systems Inc |
| Mar 28, 2013 | DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix ... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic res... | Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. | Class II | GE Healthcare, LLC |
| Mar 28, 2013 | EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to a... | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... | Class II | Advanced Sterilization Products |
| Mar 28, 2013 | OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane i... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic ... | Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. | Class II | GE Healthcare, LLC |
| Mar 28, 2013 | Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfe... | Unable to pass catheter through outer sheath during embryo transfer | Class II | Smiths Medical ASD, Inc. |
| Mar 28, 2013 | Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in su... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable ... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0... | Customers have reported that when separating an individual package from its attached grouping, th... | Class II | Baxter Healthcare Corp. |
| Mar 28, 2013 | Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Loc... | Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Dril... | Class II | Stryker Howmedica Osteonics Corp. |
| Mar 28, 2013 | HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
| Mar 28, 2013 | Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... | Due to the process deviation, product lots in question may have been released with higher levels ... | Class II | Integra LifeSciences Corporation |
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.