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Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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DateProductReasonClassFirm
Jun 21, 2021 WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c)... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 383257... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 ... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA SELFSAFE PUR T, I.V. Catheter: Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA Self Safe, I.V. Catheter REF 3738222 Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 21, 2021 NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5... Problems related to the sterilization of the medical devices; possible missing sterility of the m... Class II Delta Med SpA
Jun 3, 2021 BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bu... Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequ... Class II Axonics Modulation Technologies, Inc.
Apr 30, 2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... The devices may not meet the minimum required sterility assurance level. Class II Medline Industries Inc
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, single use Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Olympus Sterile Optical Laser Fiber, single use and reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 26, 2021 REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 23, 2021 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Pro... Due to issue with product sterility. Sterilization service provider had falsified records. Class II Adler MicroMed, Inc.
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the potential for the device... Class II Covidien Llc
Feb 23, 2021 Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended ... Evidence of face masks or other material in the seal in several kits, causing improper seals and ... Class II Trinity Sterile, Inc.
Feb 22, 2021 Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 22, 2021 AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 12, 2021 PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... Teleflex is recalling this product due to a lack of assurance of sterility. Class II TELEFLEX MEDICAL INC
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which could impact the seal ... Class II Ethicon, Inc.
Dec 23, 2020 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... Class II Becton Dickinson & Company
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Nov 25, 2020 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.

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.