Browse Device Recalls

2,032 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,032 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 2,032 FDA device recalls in NJ.

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DateProductReasonClassFirm
Sep 20, 2024 SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties a... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CO... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgica... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. Class I Maquet Cardiovascular, LLC
Sep 20, 2024 SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 17, 2024 MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... There is discrepant labeling on the inner and outer packaging of the device. Class II Datascope Corp.
Sep 17, 2024 The IMAGEnet 6 Ophthalmic Data System is a software program that is intended ... The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in th... Class II Topcon Medical Systems, Inc.
Sep 13, 2024 MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/A... There is a potential for pinholes in the applicator pouch film which creates a sterility concern. Class II Integra LifeSciences Corp.
Sep 13, 2024 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... Class III DRG International, Inc.
Sep 4, 2024 Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable de... Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may pre... Class II Howmedica Osteonics Corp.
Aug 23, 2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... Class II Stryker Spine
Aug 23, 2024 Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of h... This recall was initiated due to customer complaints of false negative of hCG test results when r... Class II Princeton Biomeditech Corp
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... Class I Datascope Corp.
Aug 8, 2024 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... Class I Datascope Corp.
Aug 7, 2024 MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 Stryker has identified an issue with the characterization process that impacted the constant valu... Class II Howmedica Osteonics Corp.
Aug 5, 2024 Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs ... A patient specific, custom-made device was supplied for a surgical procedure that did not match t... Class II Howmedica Osteonics Corp.
Jul 22, 2024 Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provi... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024 Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024 Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to prov... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 22, 2024 Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System... V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... Class II Mindray DS USA, Inc. dba Mindray North America
Jul 9, 2024 TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV ... Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when u... Class II Integra LifeSciences Corp.
Jul 5, 2024 Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Pr... Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would... Class III DRG International, Inc.
Jun 27, 2024 LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of t... Class II LINK BIO CORP
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 19, 2024 UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in p... Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentia... Class II Howmedica Osteonics Corp.
Jun 18, 2024 BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Co... BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February ... Class II Embecta Corp.
Jun 7, 2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... Potential sheath damage that could lead to tissue damage and/or track hemorrhage. Class II Integra LifeSciences Corp.
May 31, 2024 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 31, 2024 The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use... There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-40... Class II Maquet Cardiovascular, LLC
May 29, 2024 CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical proce... Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of t... Class II Integra LifeSciences Corp.
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, a... Class II Getinge Usa Sales 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.