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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 22, 2023 | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (... | Filling process qualification did not demonstrate adequate process capability. Possible consequen... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 22, 2023 | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (... | Filling process qualification did not demonstrate adequate process capability. Possible consequen... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 22, 2023 | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... | Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... | Class II | Howmedica Osteonics Corp. |
| Dec 13, 2023 | Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... | Class I | Maquet Cardiovascular, LLC |
| Dec 13, 2023 | Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If th... | Class I | Maquet Cardiovascular, LLC |
| Dec 11, 2023 | Flow-i C40 Anesthesia System, model 6677400 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... | Class II | Getinge Usa Sales Inc |
| Dec 11, 2023 | Flow-i C30 Anesthesia System, model 6677300 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... | Class II | Getinge Usa Sales Inc |
| Dec 11, 2023 | Flow-e Anesthesia System, model 6887900 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... | Class II | Getinge Usa Sales Inc |
| Dec 11, 2023 | Flow-i C20 Anesthesia System, model 6677200 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... | Class II | Getinge Usa Sales Inc |
| Dec 11, 2023 | Flow-c Anesthesia System, model 6887700 | Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tamper... | Class II | Getinge Usa Sales Inc |
| Dec 1, 2023 | DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacem... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replaceme... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... | Class II | Maquet Cardiovascular, LLC |
| Dec 1, 2023 | LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Pa... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | DUR PCA MTK REV INS RT Intended for knee replacement Product ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | DURATION PLASTIC PATELLA-DURACON Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replace... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part N... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement P... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Numb... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replac... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | DUR PCA MTK REV INS RT Intended for knee replacement Product... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Pr... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement ... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics Corp. |
| Dec 1, 2023 | DUR PCA MTK REV INS LFT Intended for knee replacement Product N... | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated... | Class II | Howmedica Osteonics 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.