Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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Date	Product	Reason	Class	Firm
Aug 9, 2022	Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B	Products were distributed in the United States without FDA authorization or clearance.	Class I	DEWEI MEDICAL EQUIPMENT CO LTD
Aug 1, 2022	The Randox Serology I Positive Control contains the following analytes in hum...	*Update :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckm...	Class II	Randox Laboratories Ltd.
Jul 27, 2022	Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Nu...	installation issues	Class II	BARCO NV
Jul 27, 2022	ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP,...	In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.	Class II	GELITA MEDICAL GMBH
Jul 21, 2022	Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028...	The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an ...	Class II	Unomedical A/S
Jul 11, 2022	SafeControl handset (a component of the Sentida bed which moves and positions...	When the handset is disconnected from the power mains, and mains operation is restored, the hands...	Class II	WISSNER-BOSSERHOFF GMBH
Jul 4, 2022	Medicina Reusable Oral syringe 1ml Code: OTH01	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina Reusable Oral syringe 2.5ml Code: OTH25	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina Oral Tip Syringe 1ml Code: OT01	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina Reusable Oral syringe 5ml Code: OTH05	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina Oral Tip Syringe 2.5ml Code: OT25	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jul 4, 2022	Medicina Oral Tip Syringe 0.5ml Code: OT005	Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle...	Class II	Medicina Uk Ltd
Jun 22, 2022	Randox Cholesterol- For the quantitative in vitro determination of Cholester...	Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when cali...	Class II	Randox Laboratories Ltd.
Jun 9, 2022	Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF...	A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an...	Class III	Randox Laboratories Ltd.
Jun 9, 2022	Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On...	A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an...	Class III	Randox Laboratories Ltd.
Jun 2, 2022	YelloPort Elite Universal Seal. For use in laparoscopic procedures.	There is the potential that YelloPort Elite Universal Seals packaging may contain small holes whi...	Class II	Surgical Innovations Ltd
Jun 1, 2022	RayStation 9B SP1. For radiation treatment planning.	An issue with propagation of treatment course information from RayStation with RayTreat to RayCar...	Class II	RAYSEARCH LABORATORIES AB
May 30, 2022	Positron Emission Tomography and Computed Tomography System, Model: uMI 550	The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi ...	Class II	Shanghai United Imaging Healthcare Co., Ltd.
May 19, 2022	MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II	Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th...	Class II	Chromsystems Instruments & Chemicals GmbH
May 19, 2022	MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I	Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th...	Class II	Chromsystems Instruments & Chemicals GmbH
May 18, 2022	ABL800 Flex Analyzer Model Numbers 393-800 and 393-801	There is a potential for sporadic incidents of positive and negative biases for analyzer systems ...	Class II	Radiometer Medical ApS
May 13, 2022	RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MIC...	The outer package is mislabeled and the package contains a different IOL strength.	Class II	Rayner Intraocular Lenses Ltd
Apr 27, 2022	X80 RADiant Photoelectric Therapy System	There is a potential compatibility issue with the systems and replacement treatment applicators.	Class II	Xstrahl Limited
Apr 20, 2022	Proteus235- Proton Therapy System: to produce and deliver a proton beam for ...	First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning ...	Class II	Ion Beam Applications S.A.
Apr 8, 2022	XVIVO Organ Chamber REF 19020	The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ens...	Class II	XVIVO PERFUSION AB
Apr 8, 2022	Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect...	Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.	Class II	Radiometer Medical ApS
Apr 7, 2022	NanoSight NS300	Product found to not comply to Class 1 Laser safety requirement.	Class II	MALVERN PANALYTICAL LTD
Mar 25, 2022	CK MB Calibrator, Catalogue Number CK2393	Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value...	Class III	Randox Laboratories Ltd.
Mar 21, 2022	ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0...	Software issue for treatment plan and image management application may result in mismatch values ...	Class II	Varian Medical Systems Imaging Laboratory GmbH
Mar 8, 2022	OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143	Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of h...	Class II	SIMPLIVIA HEALTHCARE LTD.
Feb 28, 2022	NanoSight LM10 fitted with LM14 module. A laboratory instrument for determin...	Product found to not comply to Class 1 Laser safety requirement.	Class II	MALVERN PANALYTICAL LTD
Feb 28, 2022	NanoSight LM10 fitted with LM12 module. A laboratory instrument for determin...	Product found to not comply to Class 1 Laser safety requirement.	Class II	MALVERN PANALYTICAL LTD
Feb 25, 2022	ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon...	The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.	Class II	Brainlab AG
Feb 15, 2022	ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for...	When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range...	Class II	Ion Beam Applications S.A.
Feb 14, 2022	Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008	Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ...	Class III	Cytocell Ltd.
Feb 4, 2022	TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq...	May show unexpected locus specific signals in addition to those at 14q32.	Class III	Cytocell Ltd.
Jan 31, 2022	STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap...	Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,...	Class I	SD Biosensor, Inc.
Jan 20, 2022	Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell...	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.	Class II	Surgical Innovations Ltd
Jan 20, 2022	Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar...	Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.	Class II	Surgical Innovations Ltd
Jan 18, 2022	Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only	Incorrect marketing label (25 mm) was applied to product size 20 mm.	Class II	Merete Medical GmbH
Jan 18, 2022	Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c...	individual components have been labelled with incorrect colours. The red and green colours are op...	Class II	Cytocell Ltd.
Jan 11, 2022	CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/...	Retinal analysis system software has some features, based on artificial intelligence, that potent...	Class II	Diagnos Inc
Dec 30, 2021	RayStation/RayPlan- designed for treatment planning and analysis of radiation...	If a new primary image set is selected while the cine loop is running, the primary image set will...	Class II	RAYSEARCH LABORATORIES AB
Dec 17, 2021	Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI...	One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.	Class III	LivaNova Deutschland GmbH
Dec 13, 2021	The EnPlace is a single use trans-vaginal pelvic floor repair system which en...	Certain lots may not have been packaged wth the Channel Tube Limiter.	Class II	FEMSelect Ltd
Dec 10, 2021	THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA	This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. Th...	Class II	Mallinckrodt Pharmaceuticals Ireland Ltd
Dec 8, 2021	R82 by ETAC Push Brace for High-Low	The chrome surface of the push brace can crack during use, potentially cutting the user.	Class II	R82 A/S
Dec 8, 2021	Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model ...	There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needl...	Class II	Technomed Europe

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.