Browse Device Recalls

2,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,057 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 2,057 FDA device recalls in NJ.

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DateProductReasonClassFirm
Dec 3, 2021 ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing a... lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incor... Class II Konica Minolta Healthcare Americas, Inc.
Dec 2, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Returned test kits were erroneously shipped to customers. The kits are intended for Research Use ... Class I CELLTRION USA INC
Dec 1, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis... The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ... Class II CELLTRION USA INC
Dec 1, 2021 Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated... Class II Maquet Cardiovascular, LLC
Nov 24, 2021 Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage... Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel ... Class II Howmedica Osteonics Corp.
Nov 16, 2021 cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material... Roche has identified a small number of cobas Liat analyzer units that have consistently high nois... Class II Roche Molecular Systems, Inc.
Nov 15, 2021 Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0... Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... Class I Datascope Corp.
Nov 15, 2021 Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0... Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic... Class I Datascope Corp.
Oct 18, 2021 Total Thyroxine (T4) ELISA; REF EIA-1781 Firm has identified two lots of product that do not meet product shelf life, resulting in failed ... Class II DRG International, Inc.
Oct 15, 2021 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 XXX Class II Howmedica Osteonics Corp.
Oct 15, 2021 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 There is a potential for the outer white Tyvek lid to debond from the sealed package. Class II Howmedica Osteonics Corp.
Sep 27, 2021 BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used... Holes in product packaging impacts package integrity and may compromise sterility. Class II Becton Dickinson & Company
Sep 21, 2021 Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Card... A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum run... Class I Datascope Corp.
Sep 10, 2021 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (I... VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Co... Class II Ortho Clinical Diagnostics Inc
Sep 8, 2021 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7... The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in... Class II Datascope Corp.
Sep 8, 2021 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7... The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b... Class II Datascope Corp.
Sep 8, 2021 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3... The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in... Class II Datascope Corp.
Sep 8, 2021 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3... The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b... Class II Datascope Corp.
Sep 3, 2021 cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog N... False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas... Class II Roche Molecular Systems, Inc.
Aug 27, 2021 Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft versi... When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or Ver... Class II PTW NORTH AMERICA CORPORATION
Aug 4, 2021 cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catal... Customers have reported an increased number of false positive SARS-CoV-2 results. Class II Roche Molecular Systems, Inc.
Jul 14, 2021 Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ... There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ... Class II Maquet Medical Systems USA
Jul 14, 2021 Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrum... Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E... Class II Pentax of America Inc
Jul 14, 2021 Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-27... Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E... Class II Pentax of America Inc
Jul 1, 2021 Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a w... Class II Howmedica Osteonics Corp.
Jun 1, 2021 CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hem... Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's... Class II Integra LifeSciences Corp.
May 27, 2021 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele... Telepack may not power on when using the 3AA battery cradle. Class III Mindray DS USA, Inc. dba Mindray North America
May 18, 2021 Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, ... The products experienced a 12-hour excursion from the required refrigerated temperature condition... Class II Stryker Spine
May 18, 2021 Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, G... The products experienced a 12-hour excursion from the required refrigerated temperature condition... Class II Stryker Spine
Apr 21, 2021 Pentax Medical Video Duodenoscope - Product Usage: intended to be used with e... IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duo... Class II Pentax of America Inc
Mar 29, 2021 AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surg... 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery Class II Musculoskeletal Transplant Foundation, Inc.
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intende... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 29, 2021 NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intend... Not manufactured to specification Class II Nobel Biocare Procera LLC
Mar 25, 2021 cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coron... Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us... Class II Roche Molecular Systems, Inc.
Mar 25, 2021 cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catal... Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) us... Class II Roche Molecular Systems, Inc.
Mar 22, 2021 Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 22, 2021 Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 17, 2021 CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Cathe... Incorrect labeling, Catheter did not have the required holes and markings Class II Integra LifeSciences Corp.
Mar 11, 2021 Tritanium X TL Instruments - intervertebral fusion device with bone graft, lu... Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The... Class II Stryker Spine
Mar 5, 2021 Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re... The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L... Class II Howmedica Osteonics Corp.
Feb 22, 2021 Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 ... BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation... Class II Mindray DS USA, Inc. dba Mindray North America
Feb 16, 2021 MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE... Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon ... Class II Vectornate USA Inc
Feb 11, 2021 Operating Table System There is a potential for hydraulic leakage at the inclination function to occur resulting in an u... Class II Getinge Group Logistics America, LLC
Feb 10, 2021 Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,... Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Bas... Class II Howmedica Osteonics Corp.
Jan 29, 2021 Anesthesia gas-machine - Product Usage: intended for use in administering ane... Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zer... Class II Getinge Group Logistics America, LLC
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which could impact the seal ... Class II Ethicon, Inc.
Dec 23, 2020 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... Class II Becton Dickinson & 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.