Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 31, 2017 | 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClav... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port,... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, ... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile ... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Port... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotat... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿,... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clav... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced P... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clav... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotat... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, ... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way St... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Rem... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C... | Central venous catheters may not fit over guide wire potentially causing procedure delay. | Class II | Cook Inc. |
| Jul 31, 2017 | Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Conn... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-W... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿,... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 28, 2017 | Convertors Robotic Drape with Attached Leggings; Product is packaged as Singl... | Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. | Class II | Cardinal Health 200, LLC |
| Jul 28, 2017 | Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (3... | Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophi... | Class II | C.R. Bard, Inc. |
| Jul 28, 2017 | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc.... | Needle Bond may not be able to withstand the tension force applied when the shaped needle is depl... | Class II | NXTHERA |
| Jul 28, 2017 | Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 0564... | A software failure may incorrectly set the system settings to "default" settings, creating a risk... | Class II | Roche Diagnostics Corporation |
| Jul 28, 2017 | ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the qua... | Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) wit... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 28, 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is... | Risk of unintended motion while the AIRO system is in transport mode. | Class II | Brainlab AG |
| Jul 27, 2017 | A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be u... | Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... | Class II | Zimmer Surgical Inc |
| Jul 27, 2017 | VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visuala... | The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during... | Class II | Medtronic Navigation, Inc. |
| Jul 27, 2017 | iVue 500 with iScan, D216606. Product non-contact, high resolution tomogr... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 27, 2017 | A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, In... | Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... | Class II | Zimmer Surgical Inc |
| Jul 27, 2017 | iVue with Normative Database, Device Listing Number D185549. Product Usage... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 27, 2017 | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... | A leak may allow for microbial contamination of the sterile fluid path. | Class II | Baxter Healthcare Corporation |
| Jul 27, 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ... | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... | Class II | Datascope Corporation |
| Jul 27, 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK,... | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... | Class II | Datascope Corporation |
| Jul 27, 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ... | There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... | Class II | Datascope Corporation |
| Jul 27, 2017 | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 26, 2017 | 7x10" Small Utility Positioner with Cover | Products may not meet specifications due to possible presence of metal shavings. | Class II | Molnlycke Health Care, Inc |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 35... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S ... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 9x15" Medium Utility Positioner with Cover | Products may not meet specifications due to possible presence of metal shavings. | Class II | Molnlycke Health Care, Inc |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixa... | Potential for Intra-operative breakage of driver tips | Class II | DePuy Orthopaedics, Inc. |
| Jul 26, 2017 | Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | Concorde Lift Torque Limiting Handle. Must be used with supplemental int... | Potential for Intra-operative breakage of driver tips | Class II | DePuy Orthopaedics, Inc. |
| Jul 25, 2017 | ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (... | Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen cath... | Class II | Arrow International 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.