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
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
40,910 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 · NHTSA federal recall filings · 2026-08-24
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 513 of 819
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Compon…
Smith & Nephew, Inc.
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Terumo BCT, Inc.
Plum 360 Infusion System, List number 30010.
ICU Medical Inc
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for …
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for …
Zimmer Biomet, Inc.
Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA
Ace Surgical Supply Co., Inc.
Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is in…
Encore Medical, Lp
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 1…
Epimed International
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone …
Encore Medical, Lp
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Epimed International
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
Teleflex Medical
RESONATE X4 CRT-D, Model G447, Sterile.
Boston Scientific Corporation
HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell…
Terumo BCT, Inc.
BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Cat…
Becton Dickinson & Company
RESONATE EL ICD VR, Model D432, Sterile.
Boston Scientific Corporation
Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is in…
Encore Medical, Lp
MOMENTUM X4 CRT-D, Model G138, Sterile.
Boston Scientific Corporation
Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone …
Encore Medical, Lp
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Limacorporate S.p.A
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific …
Aaren Scientific Inc.
RESONATE EL ICD DR, Model D433, Sterile.
Boston Scientific Corporation
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure …
Boston Scientific Corporation
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) In…
Bioseal Corporation
NucliSENS Lysis Buffer Extended lot for RES 76675
BioMerieux SA
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Windstone Medical Packaging, Inc.
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Zimmer Biomet, Inc.
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vas…
Invivo Corporation
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
Epimed International
VITEK2 GP-ID, REF 21342 IVD
Biomerieux Inc
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
North Star Imaging Inc
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outs…
Sorin Group USA, Inc.
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy …
Northgate Technologies, Inc.
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pha…
SCA Pharmaceuticals, LLC
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (ND…
SCA Pharmaceuticals, LLC
SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct…
SCA Pharmaceuticals, LLC
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Phar…
SCA Pharmaceuticals, LLC
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock…
SCA Pharmaceuticals, LLC
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Biosense Webster, Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Mic…
Smiths Medical ASD Inc.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Biosense Webster, Inc.
Alcon Custom Pak
Alcon Research, LTD.
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Bios S.r.l.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(…
Smiths Medical ASD Inc.
CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) p…
Smiths Medical ASD Inc.
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Biosense Webster, Inc.
Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Di…
Teleflex Medical
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
Biosense Webster, Inc.
AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Markete…
AbbVie Inc.
Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025088801
Banner Pharmacy Services, 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.