Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2026 | iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x6... | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity t... | Class II | SI-BONE, Inc. |
| Aug 12, 2026 | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue c... | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did n... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 12, 2026 | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue co... | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did no... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 10, 2026 | Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Jul 31, 2026 | Convenience kits CATARACT PACK DYNJ59881A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 23, 2026 | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N | The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for... | Class II | Medline Industries, LP |
| Jul 23, 2026 | Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection... | Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially... | Class I | Medical Action Industries, Inc. 306 |
| Jul 23, 2026 | Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs... | Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially... | Class I | Medical Action Industries, Inc. 306 |
| Jul 14, 2026 | Halyard IV Start Kit Non-Sterile REF: KRIV26-02 | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which la... | Class II | AVID Medical, Inc. |
| Jul 6, 2026 | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride I... | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance... | Class I | Spectra Medical Devices, Llc |
| Jun 23, 2026 | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-2... | Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility a... | Class II | Arrowhead DE LLC |
| Jun 12, 2026 | Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2)... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; ... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC0... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CD... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) P... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, ... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS8600... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG D... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM14... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 12, 2026 | Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYN... | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... | Class II | Medline Industries, LP |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 9, 2026 | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... | Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... | Class II | Zimmer Surgical Inc |
| Jun 1, 2026 | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF... | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | Arterial Line Kit 20ga x 6, REF: 400115A | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| Jun 1, 2026 | General Biospy Tray, REF: GUTS1000 | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall reca... | Class I | Argon Medical Devices, Inc |
| May 21, 2026 | Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain exp... | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures... | Class II | Karl Storz Endoscopy |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the b... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 19, 2026 | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the be... | The external sterile packaging was found adhered to the internal sterile packaging, potentially c... | Class II | DEPUY (IRELAND) |
| May 18, 2026 | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing... | Sterile wound dressing, lacks sterility assurance | Class II | DeRoyal Industries Inc |
| Apr 29, 2026 | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Sterile anchors my lack sterility assurance. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 22, 2026 | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 21, 2026 | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
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.