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 162 of 808
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Encore Medical, LP
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
Stryker Corporation
VERIQUICK PREGNANCY TEST 1CT, SKU 901260
Family Dollar Stores, Llc.
BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
B. Braun Medical, Inc.
BD Alaris PCU REF 8015
CareFusion 303, Inc.
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Medtronic Neuromodulation
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN…
Nova Biomedical Corporation
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Coapt LLC
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive i…
Siemens Medical Solutions USA, Inc
Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9…
Asensus Surgical Inc
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Corin Ltd
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Randox Laboratories Ltd.
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Abbott
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Siemens Medical Solutions USA, Inc
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 S…
Nova Biomedical Corporation
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Randox Laboratories Ltd.
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Smiths Medical ASD Inc.
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Covidien
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Randox Laboratories Ltd.
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
MICROVENTION INC.
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A00005…
Baxter Healthcare Corporation
RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, …
RAYSEARCH LABORATORIES AB
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Covidien
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
Randox Laboratories Ltd.
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Corin Ltd
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview…
Maquet Cardiovascular, LLC
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Cepheid
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Covidien
Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold …
Quest Medical, Inc.
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Randox Laboratories Ltd.
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, R…
Cosmedent, Inc.
Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
Cepheid
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Coapt LLC
UncleWu Life Recalls Infant Bath Seats Due to Drowning Hazard; Violation of Bath Seat Requirements; Sold Exclusively on Amazon.com (Recall Alert)
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Cardinal Health 200, LLC
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
GE Healthcare
LAVH, REF BBLV21C
American Contract Systems, Inc.
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Universal Meditech Inc.
Robotics Pack SAH, REF SAR530M
American Contract Systems, Inc.
Robotics Pack, REF SJVO56B
American Contract Systems, Inc.
Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
Cardinal Health 200, LLC
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Universal Meditech Inc.
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
SynCardia Systems LLC
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Universal Meditech Inc.
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Omega Medical Imaging, Inc.
Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
B. Braun Medical, Inc.
DiagnosUS Pregnancy Test Midstream REF 100-17
Universal Meditech Inc.
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.