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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Oct 3, 2024 | MEERA CL mobile operating table - Designed for the placement and positioning ... | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table ... | Class II | Getinge Usa Sales Inc |
| Sep 26, 2024 | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | Out of specification endotoxin levels. | Class II | Integra LifeSciences Corp. |
| Sep 25, 2024 | Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Produc... | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned p... | Class II | Ethicon, Inc. |
| Sep 22, 2024 | ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of EL... | Potential challenge with intraoperative assembly of the external taper of a single midsection wit... | Class II | Onkos Surgical, Inc. |
| Sep 20, 2024 | SURG PAT XRAY 1X1 Model/Catalog Number: 801403. 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 1/4X6 Model/Catalog Number: 801450. 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 1/2X3 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 |
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.