Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 10, 2014 | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixatio... | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result... | Class II | Synthes, Inc. |
| Apr 9, 2014 | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:... | Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a prod... | Class II | Ev3, Inc. |
| Apr 7, 2014 | SBi RingFix Olive Wires Product Usage: These are temporary devices indica... | Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-30... | Class II | Small Bone Innovations, Inc. |
| Apr 4, 2014 | Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against h... | Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present i... | Class II | BD Biosciences, Systems & Reagents |
| Apr 3, 2014 | AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... | Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... | Class II | Baxter Healthcare Corp. |
| Apr 2, 2014 | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculat... | 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values durin... | Class I | Baxter Corporation Englewood |
| Mar 28, 2014 | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE... | Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ C... | Class II | Terumo Cardiovascular Systems Corp |
| Mar 28, 2014 | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number... | New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfi... | Class II | Integra LifeSciences Corporation |
| Mar 26, 2014 | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, P... | May be labeled with incorrect result interpretation graphics on the ToxCup lid label. | Class II | Branan Medical Corporation |
| Mar 25, 2014 | Reusable latex breathing bags with multiple part numbers and sold as part of ... | Reusable latex breathing bags with various part numbers and sold as part of test lung and reusabl... | Class II | Draeger Medical, Inc. |
| Mar 24, 2014 | AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5... | There is a possibility the sterile packaging may fail before the expiration date specified on the... | Class II | Soma Access Systems LLC |
| Mar 19, 2014 | DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment,... | During a transfer of products from a recently shutdown facility, the firm discovered raw material... | Class II | Zimmer, Inc. |
| Mar 19, 2014 | Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatmen... | During a transfer of products from a recently shutdown facility, the firm discovered raw material... | Class II | Zimmer, Inc. |
| Mar 19, 2014 | Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral st... | During a transfer of products from a recently shutdown facility, the firm discovered raw material... | Class II | Zimmer, Inc. |
| Mar 19, 2014 | Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides com... | During a transfer of products from a recently shutdown facility, the firm discovered raw material... | Class II | Zimmer, Inc. |
| 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 | 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 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 | 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 | 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 5, 2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... | The outer package label contained the incorrect length of the device. There is a label on the out... | Class II | Pega Medical Inc. |
| Feb 27, 2014 | Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 27, 2014 | Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 27, 2014 | Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... | Class II | Medtronic Neuromodulation |
| Feb 27, 2014 | PowerPort Slim Implantable Port, indicated for patient therapies requiring re... | Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, h... | Class II | Bard Access Systems |
| Feb 26, 2014 | Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biom... | Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... | Class II | Biomet, Inc. |
| Feb 26, 2014 | Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique an... | Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was ide... | Class II | Biomet, Inc. |
| Feb 26, 2014 | Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Bi... | Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... | Class II | Biomet, Inc. |
| Feb 26, 2014 | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GS... | Class II | Leica Microsystems, Inc. |
| Feb 19, 2014 | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,... | The bar code that is printed on the Master Carton label does not correspond to the product code f... | Class III | Medefil Incorporated |
| Feb 18, 2014 | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0... | Some of the discs may not be impregnated with the antibiotic. | Class II | Remel Inc |
| Feb 17, 2014 | Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton... | WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due t... | Class II | WalkMed Infusion, LLC |
| Feb 14, 2014 | Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... | Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed ... | Class II | Spacelabs Healthcare, Llc |
| Feb 10, 2014 | BencoDental tartar & stain remover ultrasonic cleaning solution Product Us... | As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is r... | Class II | Heraeus Kulzer, LLC. |
| Feb 7, 2014 | FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... | Packaging error -- two different types and sizes of acetabular liners used during hip replacement... | Class II | Djo Surgical |
| Feb 6, 2014 | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... | Incorrect master label. | Class III | Medtronic Vascular |
| Feb 5, 2014 | Synthes 5.0mm Variable Locking Screw This device is part of the Variable A... | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 ... | Class II | Synthes, Inc. |
| Feb 5, 2014 | Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... | Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number... | Class II | Alere San Diego, Inc. |
| Feb 3, 2014 | OneTray Sealed Sterilization Containers Product Usage: A rigid sterilizat... | The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at ... | Class II | Innovative Sterlization Technologies LLC |
| Jan 30, 2014 | Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i... | The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, tap... | Class II | Synthes, Inc. |
| Jan 28, 2014 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopte... | Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. | Class II | AMO Puerto Rico Manufacturing, Inc. |
| Jan 27, 2014 | Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade an... | Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. | Class II | Synthes, 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.