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.

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DateProductReasonClassFirm
Dec 12, 2017 Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 087147... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 ... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 11, 2017 digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/... It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may ... Class II Philips Electronics North America Corporation
Dec 11, 2017 Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek ... Class II Smith & Nephew, Inc.
Dec 11, 2017 Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Us... Contamination with Methylbacterium thiocyanatum Class II Sanofi Genzyme
Dec 8, 2017 Widefield OCT software feature for the Spectralis HRA+OCT and variants FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefiel... Class II Heidelberg Engineering
Nov 21, 2017 Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is mar... The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Li... Class II Medica Corporation
Nov 20, 2017 Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The ... The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the ex... Class II OMNIlife science Inc.
Nov 17, 2017 IntelliVue X3 Patient Monitor. The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instea... Class II Philips Electronics North America Corporation
Nov 13, 2017 HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline co... A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection... Class II Lifeline Systems Company
Nov 10, 2017 NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStag... Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatme... Class II NxStage Medical, Inc.
Nov 9, 2017 ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: T... Certain catheters could have a compromised catheter shaft due to a manufacturing defect which cou... Class II Vascular Insights, LLC
Nov 3, 2017 bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (... The protective shield was retracted, and the blade was exposed. Class II Beaver-Visitec International Inc.
Nov 3, 2017 bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b... The protective shield was retracted, and the blade was exposed. Class II Beaver-Visitec International Inc.
Nov 3, 2017 bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Produc... The protective shield was retracted, and the blade was exposed. Class II Beaver-Visitec International Inc.
Nov 3, 2017 bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o... The protective shield was retracted, and the blade was exposed. Class II Beaver-Visitec International Inc.
Nov 3, 2017 bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 ... The protective shield was retracted, and the blade was exposed. Class II Beaver-Visitec International Inc.
Nov 1, 2017 ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811... Certain lots of disposable laparoscopic instrument tips may potentially have a compromised steril... Class II Microline Surgical, Inc.
Nov 1, 2017 ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 008110990121... Certain lots of disposable laparoscopic instrument tips may potentially have a compromised steril... Class II Microline Surgical, Inc.
Oct 27, 2017 L3 Security & Detection System Cabinet X-ray system used for security screeni... L3 has determined in airport environments, there have been several cases where a small air gap ha... Class II L3 Security & Detection
Oct 24, 2017 Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an ... Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as... Class II Medtronic Minimally Invasive Therapies Group
Oct 19, 2017 CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnos... The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with ... Class II Philips Electronics North America Corporation
Oct 16, 2017 STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Numbe... A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in th... Class III Keystone Dental Inc
Oct 14, 2017 MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved... Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen... Class II Medtronic Minimally Invasive Therapies Group
Oct 6, 2017 Allen Medical Bow Frame Model A-70800. Surgical platform used to position pa... The base of the frame has the potential to crack when the patient is initially transferred to the... Class II Allen Medical Systems
Oct 6, 2017 Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position... The base of the frame has the potential to crack when the patient is initially transferred to the... Class II Allen Medical Systems
Oct 5, 2017 2008T, Hemodialysis Delivery System Product Indicated for acute and chroni... While reviewing documentation for the next software release of the 2008T, an R&D technician ident... Class II Fresenius Medical Care Renal Therapies Group, LLC
Oct 5, 2017 Philips Network Firewall (Cisco ASA 5506), Model # 867098 Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic ma... Class II Philips Electronics North America Corporation
Oct 4, 2017 INFINITY DUAL HEMO MCable Pod Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinit... Class II Draegar Medical Systems, Inc.
Sep 30, 2017 O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02... During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is po... Class II Medtronic Navigation, Inc.-Littleton
Sep 29, 2017 NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter... The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected... Class II Fresenius Medical Care Renal Therapies Group, LLC
Sep 28, 2017 Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will... Class II Philips Electronics North America Corporation
Sep 26, 2017 AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ i... If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is ... Class II Mobius Imaging, LLC
Sep 22, 2017 Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be ... Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... Class II Boston Scientific Corporation
Sep 22, 2017 Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intende... Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... Class II Boston Scientific Corporation
Sep 20, 2017 Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcar... Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %Do... Class III Philips Electronics North America Corporation
Aug 31, 2017 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set i... Leakage of FMS gravity tub sets (281113) at the bulb and tube connection Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 25, 2017 Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants ... The recalled units are mislabeled with an incorrect expiration date. The expiration date printed ... Class II Keystone Dental Inc
Aug 23, 2017 IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP... Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors Class II Philips Electronics North America Corporation
Aug 18, 2017 Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, ... When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurement... Class II Philips Electronics North America Corporation
Aug 15, 2017 EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing De... The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have result... Class II NDDd Medical Technologies, Inc.
Aug 15, 2017 EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Mo... The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have result... Class II NDDd Medical Technologies, Inc.
Aug 4, 2017 OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 021... A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator ... Class II ZOLL Medical Corporation
Aug 2, 2017 Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications... Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak du... Class II Haemonetics Corporation
Aug 2, 2017 JANUS & JANUS G3 Automated Workstation is an automated programmable liquid h... We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were... Class III Perkinelmer Life Sciences, Inc.
Aug 2, 2017 Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 Instrumentation Laboratory Co. received customer reports of performance issues with some vials of... Class II Instrumentation Laboratory Co.
Aug 2, 2017 Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications f... Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak du... Class II Haemonetics 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

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.