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 · 2026-09-28
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
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 167 of 822
Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
Shirakawa Olympus Co., Ltd.
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA; f) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX; g) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA; h) XS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC; i) X
Baxter Healthcare Corporation
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
Baxter Healthcare Corporation
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM
Bard Peripheral Vascular Inc
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
Seaway Pharma Inc.
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
Seaway Pharma Inc.
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
Seaway Pharma Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F,
Merit Medical Systems, Inc.
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
Insulet Corporation
Regard Dressing change kit, Item Number 800026006
ROi CPS LLC
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Beaver Visitec International, Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medtronic Inc.
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Busse Hospital Disposables, Inc.
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Encore Medical, LP
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Merit Medical Systems, Inc.
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Natus Medical Incorporated
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Keystone Industries
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Natus Medical Incorporated
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Encore Medical, LP
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Beaver Visitec International, Inc.
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Busse Hospital Disposables, Inc.
Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Abiomed, Inc.
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Busse Hospital Disposables, Inc.
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Covidien
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Zimmer Biomet Spine Inc.
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Merit Medical Systems, Inc.
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349
Randox Laboratories Ltd.
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP
Philips Respironics, Inc.
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical Corporation
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Landauer
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.
Acumed LLC
Alinity ci-series System Control Module, REF: 03R70-01
Abbott Laboratories
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medtronic Neuromodulation
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medline Tracheostomy Care Kit with Glove, REF CC4681A, Sterile; (5) Medline Mini Tracheostomy Care Kit, REF CC3T3030A, Sterile; and (6) Medline Mini Tracheostomy Care Kit, REF DYND40622, Non-sterile.
MEDLINE INDUSTRIES, LP - Northfield
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
DeRoyal Industries Inc
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Medtronic Neuromodulation
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Megadyne Medical Products, Inc.
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Megadyne Medical Products, Inc.
Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 AS
Steris Corporation
Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
Megadyne Medical Products, Inc.
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Fresenius Medical Care Holdings, Inc.
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Megadyne Medical Products, Inc.
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
MEDLINE INDUSTRIES, LP - Northfield
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
MEDLINE INDUSTRIES, LP - Northfield
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Fresenius Kabi USA, LLC
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
CardioQuip, LLC
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Karl Storz Endoscopy
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
CardioQuip, 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 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.