Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 18, 2014 | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists... | Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when ... | Class III | Nanosphere, Inc. |
| Mar 17, 2014 | 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Ste... | Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospita... | Class II | 3M Company - Health Care Business |
| Mar 17, 2014 | SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the servi... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients... | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and ... | Class II | Arjo Hospital Equipment AB |
| Mar 17, 2014 | Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. T... | A reagent contained within the product may return false negative results. | Class II | Remel Inc |
| Mar 17, 2014 | Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended f... | Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the ... | Class II | Smiths Medical ASD, Inc. |
| Mar 17, 2014 | BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the s... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the ... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the ser... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50... | The footboard of Patient support for stitching can be fixed in upper position. When the fix clam... | Class II | Philips Medical Systems, Inc. |
| Mar 17, 2014 | Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended... | Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the ... | Class II | Smiths Medical ASD, Inc. |
| Mar 17, 2014 | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box c... | A reagent contained within the product may return false negative results. | Class II | Remel Inc |
| Mar 17, 2014 | SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attach... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 15, 2014 | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray im... | Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices a... | Class II | Claymount Assembli |
| Mar 15, 2014 | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray im... | Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the m... | Class II | Claymount Assembli |
| Mar 14, 2014 | K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The prod... | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... | Class II | Breg Inc |
| Mar 14, 2014 | Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation o... | Alcon LenSx received reports of unexpected downward motion of the gantry. | Class II | Alcon LenSx, Inc. |
| Mar 14, 2014 | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 19241... | Leak issues were discovered through accelerated age testing. | Class II | InterValve Inc |
| Mar 14, 2014 | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usa... | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... | Class II | Breg Inc |
| Mar 13, 2014 | Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-5... | Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have re... | Class II | Medtronic MiniMed Inc. |
| Mar 13, 2014 | Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) ... | The products are labeled as sterile but were not sterilized. | Class II | Merit Medical Systems, Inc. |
| Mar 13, 2014 | 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2014 | 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2014 | Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A... | The products are labeled as sterile but were not sterilized. | Class II | Merit Medical Systems, Inc. |
| Mar 13, 2014 | Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a c... | The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas ... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 13, 2014 | 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2014 | 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 11, 2014 | Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Produ... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope ... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 | Product does not meet minimum knot tensile strength requirements. | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm)... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), ... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural ... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage:... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 Weck¿ Vista" Universal Balloon Open Access Port Standard Length (70... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Trian... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck V... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product U... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product U... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product U... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 4059... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 05... | The products are being recalled because they did not meet minimum diameter requirements. | Class II | Teleflex Medical |
| Mar 11, 2014 | Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx o... | The products are being recalled because they did not meet minimum needle attachment strength requ... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933.... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
| Mar 11, 2014 | Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synth... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage:... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknate... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An en... | Complaints were received of leakage of insufflation gas through the device, which can cause diffi... | Class II | Teleflex Medical |
| Mar 11, 2014 | Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Ste... | Product does not meet minimum needle attachment strength requirements; thus, the needle can becom... | Class II | Teleflex Medical |
| Mar 11, 2014 | 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-on... | Complaints of leakage of insufflation gas through the device. | Class II | Teleflex Medical |
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.