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 175 of 822
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Stryker Corporation
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Family Dollar Stores, Llc.
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Encore Medical, LP
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Stryker Corporation
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
Stryker Corporation
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Philips North America Llc
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
B. Braun Medical, Inc.
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
Stryker Corporation
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
Securitas Healthcare LLC
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
St. Jude Medical
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Olympus Corporation of the Americas
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
Stryker Corporation
EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
Olympus Corporation of the Americas
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
Stryker Corporation
Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Securitas Healthcare LLC
30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
B. Braun Medical, Inc.
GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
Family Dollar Stores, Llc.
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Olympus Corporation of the Americas
AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.
B. Braun Medical, Inc.
Zenition 50 & 70 Mobile Surgery C-arm
Philips North America
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Baxter Healthcare Corporation
AT HOME MARIJUANA TEST STRIP, SKU 900752
Family Dollar Stores, Llc.
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Cordis US Corp
FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
Family Dollar Stores, Llc.
ORAL B MOUTH SORE RINSE 237ML, SKU 999087
Family Dollar Stores, Llc.
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Alcon Research, LLC
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
B. Braun Medical, Inc.
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
Stryker Corporation
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
B. Braun Medical, Inc.
Azurion IGTS Fixed Systems
Philips North America
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
B. Braun Medical, Inc.
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
Stryker Corporation
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
CHANGE HEALTHCARE CANADA COMPANY
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
Philips Ultrasound, Inc.
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
Stryker Corporation
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
B. Braun Medical, Inc.
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Young Dental Manufacturing I, LLC
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
Medtronic Navigation, Inc.
Integris-Allura IGTS Fixed Systems
Philips North America
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Breg Inc
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Encore Medical, LP
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.