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 · 2026-09-03
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 746 of 822
Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
Aesculap, Inc.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solution…
Ansell Sandel Medical Industries LLC
10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Ne…
ICU Medical, Inc.
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Bran…
Smiths Medical ASD, Inc.
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asant…
Asante Solutions, Inc.
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Steril…
Advanced Sterilization Products
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated wi…
GE Healthcare It
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured…
Asante Solutions, Inc.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Proce…
Steris Corporation
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once th…
Merit Medical Systems, Inc.
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for…
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for:…
Asante Solutions, Inc.
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asa…
Asante Solutions, Inc.
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15…
Stryker Medical Division of Stryker Corporation
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use f…
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for …
Philips Medical Systems, Inc.
NGK Stem Ext 24 x 245mm
Zimmer, Inc.
DIST LAT FEM LOCK PLT, RT
Zimmer, Inc.
Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequ…
Zimmer, Inc.
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative Q…
AdvanDx, Inc.
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year e…
Stryker Medical Division of Stryker Corporation
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asant…
Asante Solutions, Inc.
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indic…
Zimmer, Inc.
FEM COND BUTTRESS PLT, LT
Zimmer, Inc.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which …
Philips Medical Systems, Inc.
TIB NAIL
Zimmer, Inc.
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solut…
Asante Solutions, Inc.
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary…
Baxter Healthcare Corp.
TIBIO FEM/FEM NAIL.
Zimmer, Inc.
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire rep…
Synthes USA HQ, Inc.
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe…
Zimmer, Inc.
RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a v…
Instrumentation Industries Inc
FEM COND BUTTRESS PLT, RT.
Zimmer, Inc.
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured fo…
Asante Solutions, Inc.
ITST THREADED GUIDE PIN
Zimmer, Inc.
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing …
Steris Corporation
Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Adv…
Integra LifeSciences Corp.
DIST LAT FEM LOCK PLT, LT
Zimmer, Inc.
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Terumo Cardiovascular Systems Corporation
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Ziehm Imaging Inc
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments ar…
Edwards Lifesciences, LLC
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Ortho-Clinical Diagnostics
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspo…
SpineFrontier, Inc.
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions …
Varian Medical Systems, Inc.
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Stryker Howmedica Osteonics Corp.
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
SpineFrontier, Inc.
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
SpineFrontier, Inc.
Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Ziehm Imaging Inc
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum s…
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a gene…
EOS Imaging
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.