Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT M... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED,... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Vas Pack, Item No.888-2520, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Phleb, Item No.682-1425, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEP... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | HENRY SCHEIN, Labiaplasty PackItem No.570-3118, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Basin Pack, Item No.570-1692 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, ENT PACK, Item No.570-2718 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP I... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LE... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVER... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVE... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | HENRY SCHEIN, GYN PACK, Item No.570-2625 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT S... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOL... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED S... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM T... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | 2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm... | Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform ... | Class II | Bunnell, Inc. |
| Nov 2, 2022 | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery ... | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TI... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| Nov 2, 2022 | STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid ... | Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions... | Class II | Qvella Corporation |
| Nov 2, 2022 | STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, BREAST PACK, Item No.570-2397 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, VEIN TRAY, Item No.570-2738, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
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.