Browse Device Recalls

3,133 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,133 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 3,133 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 19, 2023	Integra Cranial access kit (without Prep solutions) Bit and Guard-For access ...	Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without...	Class II	Integra LifeSciences Corp.
Oct 19, 2023	Integra Cranial Access Kit - For access to the subarachnoid space or the late...	Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou...	Class II	Integra LifeSciences Corp.
Oct 17, 2023	Lugol s Iodine Solution 500ML, Part Number 624-71	Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap ...	Class II	EMD Millipore Corporation
Oct 16, 2023	(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Train...	The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023	(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile...	The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2023	Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with ...	The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Oct 2, 2023	Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL...	Due to product outer packaging incorrectly labeled.	Class II	Edge Biologicals Inc
Sep 25, 2023	RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: ...	Two different humeral socket Insert devices were swapped during packaging, which could result in ...	Class II	Encore Medical, LP
Sep 25, 2023	RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, ...	Two different humeral socket Insert devices were swapped during packaging, which could result in ...	Class II	Encore Medical, LP
Sep 18, 2023	DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit	DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Me...	Class II	DeRoyal Industries Inc
Sep 6, 2023	Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase...	The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the pa...	Class II	Smiths Medical ASD Inc.
Sep 5, 2023	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN...	Product was re-processed and re-sterilized by a third party using packaging configurations and a ...	Class II	Atrium Medical Corporation
Sep 5, 2023	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN...	Product was re-processed and re-sterilized by a third party using packaging configurations and a ...	Class II	Atrium Medical Corporation
Aug 24, 2023	AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324	Peripheral coil system detachable has a potential of unsealed pouch packaging.	Class II	MICROVENTION INC.
Aug 22, 2023	Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P...	The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b...	Class II	Smiths Medical ASD Inc.
Aug 7, 2023	B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (...	The sterile blister packaging may be damaged, and sterility may be compromised	Class II	B. Braun Medical, Inc.
Aug 7, 2023	B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli...	The sterile blister packaging may be damaged, and sterility may be compromised	Class II	B. Braun Medical, Inc.
Aug 3, 2023	MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit...	Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023	MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen...	Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023	MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible...	Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023	MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S...	Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jul 24, 2023	Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring ...	Sterility of device may be compromised due to breach of the chevron seal of the packaging	Class II	Cook Vandergrift, Inc.
Jul 12, 2023	IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, ...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, ...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, ...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, ...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, ...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d)...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
Jul 12, 2023	IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d...	There is a potential for a product packaging non-conformity issue which presents as a pinhole in ...	Class II	Medicrea International
May 19, 2023	NexGen Precoat Stemmed Tibial Plate Size 5	Device outer packaging was incorrectly labeled.	Class II	Zimmer, Inc.
May 18, 2023	MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLAST...	Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON...	Class II	MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023	HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypas...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary by...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iR, used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass M...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Mo...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iR, used during cardiopulmonary bypass Model ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOIN...	Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON...	Class II	MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023	MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK,...	Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON...	Class II	MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023	BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass ...	1. An accessory may be improperly placed during packaging, causing creases and damage to the acce...	Class II	Maquet Medical Systems USA
May 18, 2023	QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA
May 18, 2023	MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Mode...	Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON...	Class II	MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023	QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model ...	Product packaging may exhibit small pinholes which may not be visible to the unaided eye, comprom...	Class II	Maquet Medical Systems USA

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.