Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2015 | ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, L... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Sol... | Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot... | Class II | DeRoyal Industries Inc |
| Aug 31, 2015 | ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IP... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a... | When performing head or neck scans, the currently displayed SAR values could be lower than the ac... | Class II | GE Healthcare |
| Aug 31, 2015 | Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED... | A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed el... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Aug 31, 2015 | ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right ... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The S... | The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled M... | Class II | Synthes (USA) Products LLC |
| Aug 31, 2015 | GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR syst... | When performing head or neck scans, the currently displayed SAR values could be lower than the ac... | Class II | GE Healthcare |
| Aug 31, 2015 | GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family ... | When performing head or neck scans, the currently displayed SAR values could be lower than the ac... | Class II | GE Healthcare |
| Aug 31, 2015 | XiO Radiation Treatment Planning System. Used to create treatment plans for ... | Incorrect Treatment Delivery Using Third Party Fixed Wedges. | Class II | Elekta, Inc. |
| Aug 31, 2015 | GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging ... | When performing head or neck scans, the currently displayed SAR values could be lower than the ac... | Class II | GE Healthcare |
| Aug 31, 2015 | ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral ... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial C... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 ... | When performing head or neck scans, the currently displayed SAR values could be lower than the ac... | Class II | GE Healthcare |
| Aug 31, 2015 | DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (T... | Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot... | Class II | DeRoyal Industries Inc |
| Aug 31, 2015 | MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tou... | Once tested, it is required that the tourniquet be returned to its Ready position then placed in ... | Class II | Pyng Medical Corporation |
| Aug 31, 2015 | ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog ... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 31, 2015 | ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral ... | May contain small amounts of ethylene glycol residue | Class II | ConforMIS, Inc. |
| Aug 28, 2015 | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 1072303... | ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the r... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 27, 2015 | BD AffirM VPIII Microbial Identification Test | BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) o... | Class II | Becton Dickinson & Co. |
| Aug 27, 2015 | Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes | Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the ... | Class II | Arrow International Inc |
| Aug 27, 2015 | Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 U... | Possible loosening of the dental tool, which may lead to potential swallowing of the tool. | Class II | Bien Air Dental SA |
| Aug 27, 2015 | CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata... | CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. | Class III | Becton, Dickinson and Company, BD Biosciences |
| Aug 27, 2015 | Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables u... | Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned c... | Class III | Alere San Diego, Inc. |
| Aug 27, 2015 | MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for ste... | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling Syst... | Class II | Viewray Incorporated |
| Aug 27, 2015 | Zimmer Guide Wires for orthopedic procedures. | Product labeling of these sterile guide wires (external carton label and patient record label) st... | Class II | Zimmer, Inc. |
| Aug 27, 2015 | Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesth... | Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during... | Class II | B. Braun Medical, Inc. |
| Aug 26, 2015 | ThruPort Knot Pusher. This device is sold individually (Model KP1) and as par... | The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fra... | Class II | Edwards Lifesciences, LLC |
| Aug 26, 2015 | syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a cl... | Software Issues. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2015 | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom pro... | The kits contain pressure monitoring kits or sets which are being recalled as a result of flow re... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical k... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | NuOSS Cancellous Intended for use in dental surgery. | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous produ... | Class II | Collagen Matrix Inc |
| Aug 25, 2015 | Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for car... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F S... | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... | Class II | Boston Scientific Corporation |
| Aug 25, 2015 | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular s... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal... | Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commer... | Class II | Cardinal Health |
| Aug 25, 2015 | Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Deliver... | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... | Class II | Boston Scientific Corporation |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Te... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
| Aug 24, 2015 | R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx o... | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Class II | Teleflex Medical |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 24, 2015 | Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical. | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. | Class II | Teleflex Medical |
| Aug 24, 2015 | Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/... | Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performanc... | Class II | Terumo Cardiovascular Systems Corp |
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.