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Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
Dec 17, 2025 Genesis Knotless Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... Class II Aju Pharm Co., Ltd.
Dec 17, 2025 Fixone Hybrid Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... Class II Aju Pharm Co., Ltd.
Dec 17, 2025 Fixone Biocomposite Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... Class II Aju Pharm Co., Ltd.
Dec 17, 2025 Genesis Push-In Suture Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... Class II Aju Pharm Co., Ltd.
Dec 17, 2025 AlternatiV+ Screw-In Anchor Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... Class II Aju Pharm Co., Ltd.
Dec 16, 2025 Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2.... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTREC... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTIC... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS07... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 25GA Subretinal Injection Cannula VS0220.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Tecfen Retractable Membrane Polisher, QTPR1267-23 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 I... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS02... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical I2 Injection Kit, VS0500 There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical TID Pharos Illuminated Depressor, VS0801B XXX Class II Vortex Surgical Inc.
Dec 16, 2025 Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA L... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, ... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY ... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA C... There may be voids located in the seal of Tyvek pouches associated with identified catalog number... Class II Vortex Surgical Inc.
Dec 15, 2025 Allura Xper FD20; Model Number: 722006; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10; Model Number: 722026; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 Nasal feeding tube packaged without the nasal transfer tube component. Class II Wilson-Cook Medical Inc.
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722013; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20 OR Table; Model Number: 722023; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Presence of particulates in affected devices that can be deposited into breast tissue during use. Class II Hologic, Inc
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Plum Duo Infusion System, List Number 40002-04-01 ICU Medical received one lot of defective primary speakers from our supplier that may fail to pro... Class II ICU Medical, Inc.
Dec 15, 2025 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Allura Xper FD20 Biplane; Model Number: 722008; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sampl... Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, a... Class II Sysmex America, Inc.
Dec 15, 2025 Allura Xper FD10; Model Number: 722010; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021... Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... Class II ICU Medical, Inc.
Dec 15, 2025 Allura Xper FD20/10; Model Number: 722029; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit ... Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted... Class II Diagnostica Stago, Inc.
Dec 15, 2025 Allura Xper FD20; Model Number: 722012; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722005; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M... The console label for affected devices is missing the "DANGER" symbol. Class II LEASEIR TECHNOLOGIES SLU
Dec 15, 2025 Allura Xper FD20/20; Model Number: 722038; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD10/10; Model Number: 722011; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001... Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... Class II ICU Medical, Inc.
Dec 15, 2025 ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ... Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... Class II ICU Medical, Inc.
Dec 15, 2025 Allura Xper FD10; Model Number: 722003; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Product Name: Allura Xper FD10C; Model number: 722001; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025 Allura Xper FD20; Model Number: 722028; Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.