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 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 2, 2022	Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURG...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Surgipro II Monofilament Polypropylene Sutures Product Description Model Num...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6...	Integra LifeSciences identified that one lot was released with out-of-specification endotoxin res...	Class II	Integra LifeSciences Corp.
Dec 2, 2022	Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSI...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L	Affected lots of the product are being recalled due to potential microbial growth in the fluid in...	Class II	Tomy International Inc.
Dec 2, 2022	Surgidac Uncoated Braided Polyester suture Product Description D-17...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TIC...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-182...	The stylet is longer than specified on the label	Class II	Remington Medical, Inc.
Dec 2, 2022	Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 C...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Dec 2, 2022	Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-...	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic proced...	Class II	Covidien, LP
Nov 30, 2022	Source Administration Set (SAS) used with the Medrad Intego PET Infusion Syst...	Black specks may be present on the packaged needles	Class II	Bayer Medical Care, Inc.
Nov 30, 2022	Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente...	Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility...	Class II	Beaver Visitec International, Inc.
Nov 30, 2022	ActiveAid 922, Shower/Commode Chair	Device manufactured with a component with affects the foldability of the frame, not allowing it t...	Class II	Altimate Medical, Inc.
Nov 29, 2022	Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6...	Distribution without Pre-Market Clearance	Class II	Acumed LLC
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1104JP	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1205	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare Model 1102	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S...	Distribution without Pre-Market Clearance	Class II	Acumed LLC
Nov 29, 2022	HeartWare HVAD Pump Kit, REF MCS1705PU	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Scr...	Distribution without Pre-Market Clearance	Class II	Acumed LLC
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1104	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1103	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80m...	Distribution without Pre-Market Clearance	Class II	Acumed LLC
Nov 29, 2022	OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For...	Product missing the four small locking collar bolts resulting in extension of surgery to find a r...	Class II	Biomet, Inc.
Nov 29, 2022	HeartWare Model 1101	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare HVAD Pump Kit, REF 1104CA-CLIN	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 29, 2022	HeartWare Model 1100	Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ...	Class II	Heartware, Inc.
Nov 28, 2022	Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes...	Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer...	Class I	Universal Meditech Inc.
Nov 28, 2022	DeRoyal Tonsillectomy Tray, REF 89-10698.01	DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot ...	Class II	DeRoyal Industries Inc
Nov 24, 2022	RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used ...	Complaints of leaking packets were received.	Class I	Emergent Protective Products USA Inc
Nov 24, 2022	Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI...	Reaction vessels may contain a potential contaminant that could affect their optical performance.	Class III	Abbott Laboratories
Nov 23, 2022	Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re...	Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak	Class II	Baxter Healthcare Corporation
Nov 23, 2022	Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and a...	Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer	Class II	Baxter Healthcare Corporation
Nov 23, 2022	LUMINOS Lotus Max (VF11)	Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro...	Class II	Siemens Medical Solutions USA, Inc
Nov 23, 2022	Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA...	Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer	Class II	Baxter Healthcare Corporation
Nov 23, 2022	Luminos dRF Max (VE10, VF10, VF11)	Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro...	Class II	Siemens Medical Solutions USA, Inc
Nov 23, 2022	Luminos Agile Max (VE10, VF10, VF11)	Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro...	Class II	Siemens Medical Solutions USA, Inc
Nov 23, 2022	COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi...	The product is labeled with the incorrect expiration date.	Class II	Covidien, LLC
Nov 23, 2022	Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re...	Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak	Class II	Baxter Healthcare Corporation
Nov 23, 2022	Revaclear 300 dialyzers. Indicated for treatment of chronic and acute re...	Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak	Class II	Baxter Healthcare Corporation
Nov 22, 2022	Philips Upgrade to MR 7700 System, Model Number 782130	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	Philips North America Llc
Nov 22, 2022	Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090	Reports of an increase in reactive negative controls and false positive results with certain lots...	Class II	Abbott Molecular, Inc.
Nov 22, 2022	Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78...	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	Philips North America Llc
Nov 22, 2022	Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137	Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.	Class II	Philips North America Llc

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.