Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

Clear
DateProductReasonClassFirm
Nov 3, 2022 VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 During internal testing (at manufacturer site) of two torque wrench devices, it was detected that... Class II Icotec Ag
Nov 3, 2022 DeRoyal TRANS CANAL PACK, REF 89-7157.12 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal CANNULTED HIP PACK, REF 89-6977.10 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal SHOULDER KIT, REF 89-9497.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal PAIN TRAY, REF 89-10464.03 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal FOOT PACK, REF 89-9252.08 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal VIT RD PACK 86ST, REF 89-7308.09 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 XXX Class II DeRoyal Industries Inc
Nov 3, 2022 DeRoyal MYELOGRAM PACK, REF 89-9304.05 XXX Class II DeRoyal Industries Inc
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 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 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 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, 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 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, 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 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 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 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 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 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 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 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 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, 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 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 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 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 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 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 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, 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 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 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 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 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 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 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 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 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 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 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 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 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 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 CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP O... 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 GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRR... 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,1.0MM 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 HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, 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, COTTON APPLICATOR 3" Item No.505-010, 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.