Product category · Updated Aug 19, 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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
41,070 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-01
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 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 697 of 822
Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
Customed, Inc
Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irr…
Customed, Inc
Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture rem…
Customed, Inc
Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate …
Customed, Inc
Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, …
Customed, Inc
Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture …
Customed, Inc
Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound heal…
Customed, Inc
Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient care procedures such as wound healing, suture removals, ir…
Customed, Inc
Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removal…
Customed, Inc
Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform patient care procedures such as wound healing, suture removals, …
Customed, Inc
Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrig…
Customed, Inc
Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds…
Customed, Inc
Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, sut…
Customed, Inc
C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrig…
Customed, Inc
Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities o…
Stryker Neurovascular
Liposuction Pack, catalog #900-2656 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate woun…
Customed, Inc
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intend…
ConMed Corporation
Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds,…
Customed, Inc
Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
Customed, Inc
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitorin…
Microgenics Corporation
8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
Philips Medical Systems (Cleveland) Inc
8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radioth…
Vision Rt Inc
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to …
Zimmer, Inc.
8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is a…
Siemens Healthcare Diagnostics, Inc.
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine Syste…
Synthes (USA) Products LLC
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only.…
Gyrus Acmi, Incorporated
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Biomerica
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in …
Discus Dental LLC
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitab…
Hospira Inc.
8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstai…
Remel Inc
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitab…
Hospira Inc.
8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Lat…
Remel Inc
8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Abbott Molecular
Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integra…
Beevers Manufacturing & Supply, Inc.
8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Dharma Cavity Varnish 15mL
Dharma Research, Inc.
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with s…
Abbott Ireland Diagnostics Division
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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.