Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 11, 2016 | RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 103... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): ... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 9, 2016 | ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/S... | Communication provided to emphasize that the PSA values should be interpreted in accordance with ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 8, 2016 | Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrat... | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product U... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product ... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 3, 2016 | 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-... | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable | Class II | LeMaitre Vascular, Inc. |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Aug 2, 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. I... | Tip Breakage at the glue joint between the obturator body and tip | Class II | Hologic, Inc |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusi... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 29, 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infus... | Administration Set potential filter leaking | Class II | Zyno Medical LLC |
| Jul 26, 2016 | IntelliVue Patient Monitor Product Usage: The monitors are indicated for ... | If an affected Patient Monitor has been powered on continuously for several months, any displayed... | Class II | Philips Electronics North America Corporation |
| Jul 25, 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled con... | Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tu... | Class II | Terumo Cardiovascular Systems Corp |
| Jul 19, 2016 | MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, ... | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... | Class II | Philips Electronics North America Corporation |
| Jul 19, 2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... | Sterility compromised due to breach in sterile packaging | Class II | Smith & Nephew, Inc. |
| Jul 19, 2016 | UroDiagnost; x-ray system. Product Code: 708033 | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... | Class II | Philips Electronics North America Corporation |
| Jul 19, 2016 | MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036 | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... | Class II | Philips Electronics North America Corporation |
| Jul 14, 2016 | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number... | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incor... | Class II | Straumann Manufacturing, Inc. |
| Jul 14, 2016 | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Numbe... | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incor... | Class II | Straumann Manufacturing, Inc. |
| Jul 7, 2016 | T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-0... | Elevated levels of invalid results. | Class II | T2 Biosystems Inc |
| Jul 7, 2016 | Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10... | Increase in the failure rate of certain low-voltage DC power supplies (DCPS) | Class II | Philips Electronics North America Corporation |
| Jul 7, 2016 | UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD... | Increase in the failure rate of certain low-voltage DC power supplies (DCPS) | Class II | Philips Electronics North America Corporation |
| Jul 5, 2016 | Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... | Class III | Siemens Healthcare Diagnostics Inc |
| Jun 24, 2016 | Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-steriliz... | Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inac... | Class II | PerkinElmer, Inc |
| Jun 22, 2016 | AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Cl... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 22, 2016 | AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Cl... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 22, 2016 | Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 2... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 22, 2016 | Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... | Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 22, 2016 | AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip ... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 22, 2016 | Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip C... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 22, 2016 | AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip ... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 22, 2016 | Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical ... | Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in tes... | Class II | Olympus Scientific Solutions Americas |
| Jun 22, 2016 | AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip C... | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog nu... | Class II | LeMaitre Vascular, Inc. |
| Jun 16, 2016 | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 16, 2016 | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... | MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... | Class II | Ab Sciex |
| Jun 15, 2016 | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209... | The device could be subject to breaches of its sterile packaging. | Class II | Smith & Nephew, Inc. |
| May 31, 2016 | ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister u... | Cracks ATEC Canister Lids. | Class II | Hologic, Inc |
| May 24, 2016 | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-... | Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| May 2, 2016 | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for qu... | Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nm... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 14, 2016 | HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the t... | MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may hav... | Class II | Philips Electronics North America Corporation |
| Mar 31, 2016 | Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neu... | Product packaging defective compromising sterility | Class II | American Surgical Company |
| Mar 31, 2016 | American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: ... | Product packaging defective compromising sterility | Class II | American Surgical Company |
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.