Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 77 of 808
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KI…
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D …
Cardinal Health 200, LLC
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during …
Getinge Usa Sales Inc
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1…
Exactech, Inc.
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2…
Cardinal Health 200, LLC
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Max Mobility LLC
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging …
Ithera Medical Gmbh
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD…
Cardinal Health 200, LLC
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 35…
CareFusion 303, Inc.
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Stryker Corporation
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) C…
Cardinal Health 200, LLC
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
CareFusion 303, Inc.
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; …
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Cardinal Health 200, LLC
BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provid…
CareFusion 303, Inc.
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY…
Cardinal Health 200, LLC
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description:…
Hologic, Inc
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1…
Exactech, Inc.
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
CareFusion 303, Inc.
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications wi…
Medicrea International
Azurion 3 M12 System Code: (1) 722063 (2) 722221
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
LivaNova USA, Inc.
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
New Medical Technologies Gmbh
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/o…
Ethicon, LLC
IntelliVue Patient Monitor MX400. Model Number: 866060
Philips North America Llc
Optima XR646 HD. X-Ray imaging system.
GE Medical Systems, LLC
IntelliVue Patient Monitor MX450. Model Number: 866062
Philips North America Llc
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
LivaNova USA, Inc.
IntelliVue Patient Monitor MX550. Model Number: 866066
Philips North America Llc
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
GE Medical Systems, LLC
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (…
Hologic, Inc.
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
ROi CPS LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled adm…
Fresenius Kabi USA, LLC
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Oxoid Limited
IntelliVue Patient Monitor MX500. Model Number: 866064
Philips North America Llc
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20 System Code: 722031
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Ethicon, LLC
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Discovery XR656 HD. X-Ray imaging system.
GE Medical Systems, LLC
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK …
US Endodontics, LLC
AlluraXperFD20/10 System Code: (1) 722029
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Beckman Coulter, Inc.
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/15 System Code: (1) 722058
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Beckman Coulter Inc.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 2, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 2, 2026.