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 |
|---|---|---|---|---|
| Jul 1, 2015 | GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Syste... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | MOSAIQ Oncology Information System MOSAIQ is an oncology information system ... | A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment mach... | Class II | Elekta, Inc. |
| Jul 1, 2015 | GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging System... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 30, 2015 | Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic ... | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jun 30, 2015 | PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper b... | A reagent present may produce weak or slow reactions; continued use may result in a failure to id... | Class II | Remel Inc |
| Jun 30, 2015 | PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Pr... | Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are ... | Class II | BIOTRONIK, Inc. |
| Jun 30, 2015 | Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, E... | The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position fol... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jun 30, 2015 | Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For... | The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jun 30, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software... | Class II | Ortho-Clinical Diagnostics |
| Jun 30, 2015 | Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America,... | The firm discovered that the centrifugal force applied to the power supply may cause it to fail o... | Class II | Hitachi Medical Systems America Inc |
| Jun 30, 2015 | Artis zee/ zeego systems; dedicated angiography systems developed for single ... | in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray loc... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 30, 2015 | ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the qu... | A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 30, 2015 | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex ... | A reagent present may produce weak or slow reactions; continued use may result in a failure to id... | Class II | Remel Inc |
| Jun 29, 2015 | ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy... | When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guideli... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 29, 2015 | Axiom Artis systems, dedicated angiography systems developed for single and b... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automat... | Loud operating sounds, which was unacceptable to the end users when the device was powered on. Th... | Class III | Baxter Healthcare Corp. |
| Jun 29, 2015 | ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are inten... | Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy bet... | Class II | Merit Medical Systems, Inc. |
| Jun 29, 2015 | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For c... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | Artis Q systems; dedicated angiography systems developed for single and bipl... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | Vancomycin Screen Agar | The affected expired lots of product may have exhibited breakthrough growth of vancomycin suscep... | Class II | Becton Dickinson & Co. |
| Jun 29, 2015 | Siemens Artis zee systems; dedicated angiography systems developed for singl... | The possibility exists for a large amount of liquid to seep through the top cover of the table an... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2015 | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of func... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | Enterococcus Screen Agar QUAD Plate | The affected expired lots of product may have exhibited breakthrough growth of vancomycin suscep... | Class II | Becton Dickinson & Co. |
| Jun 26, 2015 | Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate p... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archi... | Firm received a complaint that the hospital had sent two accession numbers over the same morning ... | Class II | AGFA Healthcare Corp. |
| Jun 26, 2015 | Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Al... | Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the A... | Class II | Alere Scarborough, Inc. dba Binax, Inc. |
| Jun 26, 2015 | Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monop... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x10... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube p... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate p... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 26, 2015 | e.cam Gamma Camera, an emission computed tomography system. It is intended to... | Potential failure mode related to the radial brake, where the detector was able to drift, led to ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 26, 2015 | Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8... | Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated... | Class III | Getinge Disinfection Ab |
| Jun 26, 2015 | Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged:... | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... | Class II | Hardy Diagnostics |
| Jun 25, 2015 | Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic man... | Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports ... | Class II | Tornier, Inc |
| Jun 25, 2015 | ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ op... | Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 25, 2015 | ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with softw... | Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual t... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 25, 2015 | Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant compo... | it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, wa... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, ... | The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions a... | Class II | Zimmer Surgical Inc |
| Jun 24, 2015 | Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated f... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weigh... | There is a potential the sling loops may not stay attached to the carry bar hooks. | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Jun 24, 2015 | 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and... | It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. | Class II | Synthes (USA) Products LLC |
| Jun 24, 2015 | Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synth... | The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have... | Class II | Synthes (USA) Products LLC |
| Jun 24, 2015 | 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer S... | The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions a... | Class II | Zimmer Surgical Inc |
| Jun 24, 2015 | FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01... | The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anteri... | Class II | Encore Medical, Lp |
| Jun 24, 2015 | Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended... | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 24, 2015 | S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood ... | The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to ... | Class II | Roche Diagnostics Operations, Inc. |
| Jun 24, 2015 | Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished... | There is a potential the sling loops may not stay attached to the carry bar hooks. | Class II | ErgoSafe Products, LLC (DBA) Prism 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.