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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DateProductReasonClassFirm
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Mo... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Mod... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Nu... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 25, 2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 a... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 an... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 an... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-2... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 540... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 a... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 20, 2025 IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: ... IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and n... Class II Omnicell, Inc.
Feb 13, 2025 Proxima Drape labeled as FACE LIFT. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro dia... Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... Class II Remel, Inc
Feb 13, 2025 Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,1... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY ... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PAC... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; P... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnosti... Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... Class II Remel, Inc
Jan 27, 2025 Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutme... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dent... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutme... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 24, 2025 Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device M... Devices were distributed in the U.S. market without obtaining the required FDA premarket authoriz... Class II Guangzhou Pluslife Biotech Co., Ltd.
Jan 17, 2025 Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catal... Regulatory documentation error and misleading color packaging claim. Class II Zhejiang Luyao Electronics Technology Co., Ltd.
Jan 16, 2025 Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeut... Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... Class II Scientia Vascular, Inc.
Jan 10, 2025 . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP ... Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin t... Class II Nobel Biocare
Jan 10, 2025 Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... Potential that the induction seal is not completely sealed to the device tube packaging. Class II Integra LifeSciences Corp.
Jan 8, 2025 The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the ... Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Sp... Class II Hologic, Inc.
Jan 2, 2025 Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socra... Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch... Class II Scientia Vascular, Inc.

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.