Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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) ANGIOGRAPHY DRAPE P... | 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) BASIC CATARACT, 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) PAIN 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 |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, 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) PRECIP TRAY, 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) DR. KHAN CABG ADDS ... | 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 |
| 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 | 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) 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 | 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) 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) 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) 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 | Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Ste... | Five complaints received where surgeon was unable to remove and/or connect the inserter with the ... | Class II | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP P... | 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) ARTHROSCOPIE DU GEN... | 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) ANGIO CONSOLIDATED ... | 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 | Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Ca... | During some clinical cases, it has been observed that the SO2 value may periodically appear as d... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK... | 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) OCULOPLASTIC PICK P... | 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 PACK, Model N... | 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) CSTM PACEMAKER DRAP... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 28, 2025 | Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Monterey AL Implant Inserter; 22mm; Catalog 48019140. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16242 | The head of the phoropter head could come loose and potentially detach due to a default in the as... | Class II | Reichert, Inc. |
| Feb 28, 2025 | Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; | Multiple problems identified with the software version leading to various scanning and image issu... | Class II | Philips Medical Systems Nederland B.V. |
| Feb 28, 2025 | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 28, 2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16241 | The head of the phoropter head could come loose and potentially detach due to a default in the as... | Class II | Reichert, Inc. |
| Feb 27, 2025 | Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Conta... | a limited number of lots were manufactured with an incorrect cylinder power. | Class II | CooperVision, Inc. |
| Feb 27, 2025 | NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co... | The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ... | Class II | Zimmer, Inc. |
| Feb 27, 2025 | Premier Solo Diamond - Large Invented Cone; SKU: 807016C. | The hardness not meeting the material specification and may cause the diamond bur to bend. | Class II | Premier Dental Products Co |
| Feb 27, 2025 | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 | Increased risk of control failures and false negative test results with multiplexed nucleic acid ... | Class II | BioFire Diagnostics, LLC |
| Feb 27, 2025 | Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 | Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitami... | Class II | Beckman Coulter, Inc. |
| Feb 26, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ... | Class II | Beckman Coulter Inc. |
| Feb 26, 2025 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal... | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the ped... | Class II | Intuitive Surgical, Inc. |
| 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 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 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 | Veradius Unity. Product Code 718132. The devices are used for radiological gu... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Zenition 50. Product Code 718096. The devices are used for radiological guid... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| 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 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 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 | Baxter TruSystem 7500, Product Code 4091000 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
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.