Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Mar 19, 2024 Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... Nail system contains an out of specification driver-socket which could result in inability to pi... Class II TriMed Inc.
Mar 19, 2024 Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, ... Nail system contains an out of specification driver-socket which could result in inability to pi... Class II TriMed Inc.
Mar 19, 2024 Medtronic Clearview Blower/Mister, Model Number 22120 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 18, 2024 DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attai... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in a... XXX Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019,... Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to ... Class II XENEX Disinfection Services Inc.
Mar 18, 2024 GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use ... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in ... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H78710302... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in a... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... Class II Angiodynamics, Inc.
Mar 18, 2024 GE Healthcare Innova IGS 5, computed tomography x-ray system GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 15, 2024 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 15, 2024 PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TL... Due to receiving information regarding difficulties with the insertion of a setscrew inside a scr... Class II SPINEART SA
Mar 15, 2024 Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. Class II Alcon Research, LLC
Mar 15, 2024 Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 15, 2024 Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in ... Product was distributed in the United States without proper regulatory approval. Class II Baxter Healthcare Corporation
Mar 14, 2024 Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STER... Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class II Merit Medical Systems, Inc.
Mar 14, 2024 Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYN... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Tes... Due to a manufacturing variation of the irrigation sleeves which could result in a missing port h... Class II Johnson & Johnson Surgical Vision, Inc.
Mar 14, 2024 Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STE... Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class II Merit Medical Systems, Inc.
Mar 14, 2024 Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C,... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 14, 2024 Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, Their is a potential that breast implants lack the lubricious coating that allows them to slide ... Class II Allergan Sales, LLC
Mar 14, 2024 Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... Class II MEDLINE INDUSTRIES, LP - Northfield

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.