Browse Device Recalls

2,093 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,093 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 2,093 FDA device recalls in NJ.

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DateProductReasonClassFirm
Jan 21, 2016 Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temp... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the tempor... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for th... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 13, 2016 The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization... Water retention issues. Units with filters that remain wet after the sterilization may compromis... Class II PMBS, LLC
Jan 7, 2016 Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, ... MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension De... Class II Maquet Cardiovascular Us Sales, Llc
Dec 23, 2015 Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instruct... Class II Stryker Howmedica Osteonics Corp.
Dec 23, 2015 Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleani... This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 23, 2015 Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection This correction is in response to publicized reports of multi-drug resistant bacteria on endoscop... Class II Fujifilm Medical Systems U.S.A., Inc.
Dec 18, 2015 Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manu... Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. Class II Stryker Spine
Dec 16, 2015 AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody de... There were two potential interference conditions identified with the way the tubing set attaches ... Class II Stryker Spine
Dec 16, 2015 Cardiosave Hybrid and rescue IABP Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet... Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 15, 2015 Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View S... An issue with the Panorama Central Station may cause the system to spontaneously restart. This ma... Class II Mindray DS USA, Inc. dba Mindray North America
Dec 10, 2015 Flow-i Anesthesia System Product Usage: The indication for the Flow-i Ane... Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit ... Class I Maquet Cardiovascular Us Sales, Llc
Dec 9, 2015 BD Intelliport Medication Management System Sensor The system is indicated... The sterility of the product cannot be assured. This may result in increased risk of infection. Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemo... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hem... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The... Stability data does not substantiate the labeled two-year shelf life of affected product. Class II Ethicon, Inc.
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Dec 3, 2015 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD... Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additiv... Class II Becton Dickinson & Company
Nov 23, 2015 Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshiel... Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion S... Class II Terumo Medical Corp
Nov 17, 2015 BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Us... Some tubes were manufactured with the stopper not fully inserted into the tube. This may result i... Class II Becton Dickinson & Company
Nov 17, 2015 ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in... The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working pr... Class III Collagen Matrix Inc
Nov 13, 2015 Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W ... Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% vol... Class II Maquet Cardiovascular Us Sales, Llc
Oct 15, 2015 Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmed... Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the U... Class II Stryker Howmedica Osteonics Corp.
Sep 29, 2015 Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, R... Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints w... Class II Stryker Howmedica Osteonics Corp.
Sep 25, 2015 Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to p... Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because... Class II Stryker Spine
Sep 24, 2015 Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #W... Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A... Class II Airways Development LLC
Sep 21, 2015 Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib... Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants... Class II Stryker Howmedica Osteonics Corp.
Sep 21, 2015 Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator,... The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is ... Class II Valeant Pharmacueticals International
Sep 14, 2015 Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size A... SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per qual... Class II Valeant Pharmaceuticals North America LLC
Sep 8, 2015 Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine... The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated... Class II Stryker Spine
Sep 8, 2015 Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis... Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion ... Class II Stryker Howmedica Osteonics Corp.
Aug 31, 2015 Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED... A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed el... Class II Fujifilm Medical Systems U.S.A., Inc.
Aug 25, 2015 NuOSS Cancellous Intended for use in dental surgery. On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous produ... Class II Collagen Matrix 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.