Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 411 of 819
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Microline Surgical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
OriGen Biomedical, Inc.
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device inte…
Smiths Medical ASD Inc.
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of…
Zimmer Biomet, Inc.
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinica…
Bio-Rad Laboratories, Inc
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQ…
Microbiologics Inc
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201…
Accuray Incorporated
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alin…
Abbott Gmbh & Co. KG
Sterile Nail Nipper, Barrel Spring (I68400), Sterile
Centurion Medical Products Corporation
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small
Zimmer Biomet, Inc.
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Becton Dickinson & Company
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
Zimmer Biomet, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
OriGen Biomedical, Inc.
NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy sys…
NxStage Medical, Inc.
IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional…
Philips North America, LLC
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For int…
Flowonix Medical Inc
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) appl…
Leica Microsystems, Inc.
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal …
Flowonix Medical Inc
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
OriGen Biomedical, Inc.
Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
Flowonix Medical Inc
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
OriGen Biomedical, Inc.
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, an…
Philips North America, LLC
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large
Zimmer Biomet, Inc.
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, …
Stryker Neurovascular
IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a trad…
Philips North America, LLC
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
Flowonix Medical Inc
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small
Zimmer Biomet, Inc.
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Rad…
Accuray Incorporated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Sol…
Angiodynamics Inc. (Navilyst Medical Inc.)
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, R…
Stryker Corporation
Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000,…
Inopak Ltd
Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-…
Avella of Deer Valley, Inc. Store 38
Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera…
Inopak Ltd
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 22701 Material: 701050790
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
Maquet Cardiovascular, LLC
Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
Maquet Cardiovascular, LLC
Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01
Maquet Cardiovascular, LLC
Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01
Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370
Maquet Cardiovascular, LLC
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 29, 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 29, 2026.