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.

Clear

Date	Product	Reason	Class	Firm
Dec 26, 2023	GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 26, 2023	Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002	Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to ...	Class II	Ossur H / F
Dec 26, 2023	GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100...	GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ...	Class I	Wipro GE Healthcare Private Ltd.
Dec 21, 2023	HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570...	Level 3 masks were produced on alternate non-validated production equipment that were not include...	Class II	AMD Medicom Inc.
Dec 21, 2023	HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)	Level 3 masks were produced on alternate non-validated production equipment that were not include...	Class II	AMD Medicom Inc.
Dec 21, 2023	PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code ...	Level 3 masks were produced on alternate non-validated production equipment that were not include...	Class II	AMD Medicom Inc.
Dec 13, 2023	Sedecal X Optima URS digital mobile diagnostic x-ray system. A a station...	Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.	Class II	SEDECAL SA
Nov 30, 2023	bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.	An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.	Class II	B-K Medical A/S
Nov 30, 2023	Link Patella Glide Resection Guide- For the implantation of the Endo-Model Kn...	Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dim...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Nov 20, 2023	AirFit N20 Nasal Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	AirFit F30i Full Face Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	AirFit F20 Full Face Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	Calibration Serum Level 3 CAL2351	CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series inst...	Class II	Randox Laboratories Ltd.
Nov 20, 2023	AirFit N10 Nasal Masks and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	AirFit F30 Full Face Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	AirTouch N20 Nasal Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)	There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoC...	Class II	LEICA BIOSYSTEMS NUSSLOCH GMBH
Nov 20, 2023	AirTouch F20 Full Face Mask and User Guide	Masks non-invasive interface for channeling airflow to patients have magnets that have potential ...	Class I	ResMed Ltd.
Nov 20, 2023	Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry...	Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-ass...	Class II	Randox Laboratories Ltd.
Nov 13, 2023	Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level...	There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum ...	Class II	Randox Laboratories Ltd.
Nov 7, 2023	The System is designed as a modular system with components that include an Ov...	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain...	Class II	GE Hangwei Medical Systems, Co. LTD
Nov 7, 2023	The System is designed as a modular system with components that include an Ov...	GE HealthCare has become aware of the potential that incorrect torque has been applied to certain...	Class II	GE Hangwei Medical Systems, Co. LTD
Nov 6, 2023	SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assa...	A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when ...	Class III	Randox Laboratories Ltd.
Nov 3, 2023	Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura X...	Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 3, 2023	Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion ...	Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nov 3, 2023	Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automat...	Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delay...	Class II	Inpeco S.A.
Nov 1, 2023	Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a c...	Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share...	Class II	CHANGE HEALTHCARE CANADA COMPANY
Oct 30, 2023	Snapshot NIR, REF: KD204	Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the vie...	Class II	KENT IMAGING, INC.
Oct 27, 2023	PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610	Due to incorrect product labeling	Class II	Limacorporate S.p.A
Oct 25, 2023	INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040	COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April ...	Class II	PHASE SCIENTIFIC INTERNATIONAL LIMITED
Oct 17, 2023	SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System	Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.	Class II	Bebig Isotopentechnik Gmbh
Oct 13, 2023	Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revisi...	Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity...	Class II	Corin Ltd
Oct 13, 2023	Unity Total Knee System, Model Number 112.001.34. Primary and revision t...	Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity...	Class II	Corin Ltd
Oct 11, 2023	VariSoft infusion set, Model Number 1002830	The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w...	Class I	Unomedical A/S
Oct 11, 2023	VariSoft infusion set, Model Number 1002827	The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w...	Class I	Unomedical A/S
Oct 11, 2023	VariSoft infusion set, Model Number 1002828	The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported w...	Class I	Unomedical A/S
Oct 6, 2023	D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.	Customer complaint received that reported the applier failed during surgery. The applier did not ...	Class II	Peter Lazic Gmbh
Oct 6, 2023	ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot...	Users of the patient positioning system ORION System can be faced with a sudden short-term accele...	Class II	LEONI CIA CABLE SYSTEMS
Oct 6, 2023	D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.	Customer complaint received that reported the applier failed during surgery. The applier did not ...	Class II	Peter Lazic Gmbh
Oct 6, 2023	ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robot...	Users of the patient positioning system ORION System can be faced with a sudden short-term accele...	Class II	LEONI CIA CABLE SYSTEMS
Oct 6, 2023	D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.	Customer complaint received that reported the applier failed during surgery. The applier did not ...	Class II	Peter Lazic Gmbh
Oct 4, 2023	Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic...	Due to products distributed without premarket clearance or approvals.	Class II	Visgeneer, Inc.
Oct 4, 2023	Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic...	Due to products distributed without premarket clearance or approvals.	Class II	Visgeneer, Inc.
Sep 29, 2023	Alinity c Iron Reagent, Reference Number 08P3920	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm...	Class II	Sentinel CH SpA
Sep 29, 2023	IRON assay, Reference Numbers 6K95-41 and 6K95-30	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm...	Class II	Sentinel CH SpA
Sep 25, 2023	Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Mobile airway scope-diagnosis and observation to access airway anatomy, endot...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.
Sep 25, 2023	Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne...	Channel air drying process was not validated, and that a small percentage of scopes returned to c...	Class II	Aizu Olympus Co., Ltd.

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.