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 |
|---|---|---|---|---|
| Mar 23, 2015 | Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems w... | The system is designed to emit a beep upon termination of an exposure. However, if the system has... | Class II | Philips Electronics North America Corporation |
| Mar 23, 2015 | CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent | One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may... | Class II | BD Biosciences, Systems & Reagents |
| Mar 23, 2015 | ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. | Siemens internal investigation confirmed that current contamination avoidance settings do not pre... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 23, 2015 | Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 1... | Customers complained about under-recovery of non-Roche controls and discrepant low patient result... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 21, 2015 | Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. | The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in... | Class II | Smiths Medical ASD, Inc. |
| Mar 20, 2015 | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in... | The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may n... | Class II | CooperSurgical, Inc. |
| Mar 20, 2015 | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, ... | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in u... | Class II | Axis-Shield Diagnostics, Ltd. |
| Mar 20, 2015 | Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift. | Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If t... | Class II | Hill-Rom, Inc. |
| Mar 19, 2015 | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable... | A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-... | Class II | Incisive Surgical Inc |
| Mar 19, 2015 | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography syst... | potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connectio... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 19, 2015 | SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and ... | Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has recei... | Class II | Biosense Webster, Inc. |
| Mar 18, 2015 | Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total ... | Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once att... | Class II | Zimmer Gmbh |
| Mar 18, 2015 | LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Pro... | A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number... | Class II | Biomet, Inc. |
| Mar 18, 2015 | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter ... | Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Mo... | Class II | Hansen Medical Inc |
| Mar 17, 2015 | Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems... | A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 17, 2015 | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage... | A drop in staining intensity over time has been observed. These lots may not meet their labeled s... | Class II | Biocare Medical, LLC |
| Mar 17, 2015 | Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems | A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 17, 2015 | Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. ... | A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 17, 2015 | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm ... | Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kit... | Class II | Bard Peripheral Vascular Inc |
| Mar 17, 2015 | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 17, 2015 | American Catheter / Cholangiogram Catheter 9100 Series. | Catheters were not sealed before sterilization. and was not detected through subsequent acceptanc... | Class II | American Catheter Corp |
| Mar 16, 2015 | da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | Brilliance CT 40. Computed Tomography X-ray systems intended to produce cr... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to p... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek M... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pac... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Me... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical E... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Mic... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intende... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medic... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Mi... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | Brilliance CT 64. Computed Tomography X-ray systems intended to produce cr... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Med... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product ... | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient resu... | Class II | Diasorin Inc. |
| Mar 16, 2015 | Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. ... | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential fo... | Class II | Intuitive Surgical, Inc. |
| Mar 16, 2015 | Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produc... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 ... | Battery packs may heat up abnormally and ignite in rare instance. | Class II | Arcos, Inc |
| Mar 16, 2015 | Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produc... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Natus neoBLUE blanket LED Phototherapy system which includes the following it... | neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some... | Class II | Natus Medical Incorporated |
| Mar 16, 2015 | Brilliance CT 16 Power. Computed Tomography X-ray systems intended to prod... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance iCT. Computed Tomography X-ray systems intended to produce cros... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 16 Water. Computed Tomography X-ray systems intended to prod... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 15, 2015 | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies t... | Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batc... | Class II | Focus Diagnostics 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.