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.

Date	Product	Reason	Class	Firm
Dec 7, 2022	Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	Single-Use Packs, REF: OPO80	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022	Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1...	The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev...	Class I	Philips Respironics, Inc.
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Syste...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	Veritas Advanced Infusion Packs, REF: VRT-AI	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10...	The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev...	Class I	Philips Respironics, Inc.
Dec 7, 2022	Identity Shoulder System Resection Planer 35mm Resection Planer	Two planers were found to be unusable during sawbones shoulder training.	Class II	Zimmer, Inc.
Dec 7, 2022	6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ S...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single...	There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ...	Class I	Covidien LP
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJ...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra...	Stryker received one report of an injury to an untrained user that occurred while the untrained u...	Class II	Mobius Imaging, LLC
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYND...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PI...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMUL...	Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 7, 2022	FUSION Dual Pump Packs, REF: OPO73	Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific...	Class II	Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022	Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping...	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYN...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Re...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Num...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Pediatric Craniotome Ref:CRANI-P-G1	Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at...	Class II	The Anspach Effort, Inc.
Dec 7, 2022	Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY,...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022	Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder...	The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Dec 6, 2022	Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis	Device was shipped without having regulatory approval.	Class II	Stryker Leibinger GmbH & Co. KG
Dec 6, 2022	NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio...	Class II	Zimmer, Inc.
Dec 6, 2022	NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio...	Class II	Zimmer, Inc.
Dec 6, 2022	Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay...	Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside ...	Class II	Future Diagnostics Solutions B.V.
Dec 6, 2022	NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio...	Class II	Zimmer, Inc.
Dec 6, 2022	NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio...	Class II	Zimmer, Inc.
Dec 6, 2022	NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio...	Class II	Zimmer, Inc.
Dec 6, 2022	NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio...	Class II	Zimmer, Inc.
Dec 5, 2022	Agfa HealthCare Enterprise Imaging XERO Viewer	There is a software defect that can cause issues with images.	Class II	Agfa Healthcare NV
Dec 5, 2022	Oncentra Brachy radiation therapy planning system software.	A reconstruction error may occur when using the Catheter Bending functionality in Applicator Mode...	Class II	Elekta, Inc.
Dec 5, 2022	SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE...	A software update (v1.1.5) has been developed to address the issue of Critical Failure which can ...	Class I	Cardiac Assist, Inc
Dec 5, 2022	Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 ...	3D orthodontic planning software has a defect that leads to an issue where incorrect number of al...	Class II	Align Technology Inc
Dec 5, 2022	Turbett Surgical Container, TS1200: Indicated for enclosing other medical dev...	Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr...	Class II	Turbett Surgical, Inc.
Dec 5, 2022	Turbett Surgical Container, TS1000: Indicated for enclosing other medical dev...	Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr...	Class II	Turbett Surgical, Inc.
Dec 5, 2022	Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714	mislabeled product	Class III	Young Dental Manufacturing I, LLC
Dec 3, 2022	Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ...	Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502...	Class II	Medtronic Neuromodulation
Dec 3, 2022	Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ...	Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502...	Class II	Medtronic Neuromodulation
Dec 3, 2022	Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ...	Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502...	Class II	Medtronic Neuromodulation

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.