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 · 2026-08-23
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 485 of 819
T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of cir…
Menarini Silicon Biosystems
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions …
Ion Beam Applications S.A.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Zimmer Biomet, Inc.
T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Integra LifeSciences Corp.
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Siemens Healthcare Diagnostics, Inc
T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses …
Diagnostic Hybrids, Inc.
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Medtronic Vascular
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Zimmer GmbH
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic t…
Accelerate Diagnostics Inc
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827…
Cook Inc.
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Ace Surgical Supply Co., Inc.
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction…
Keystone Dental Inc
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mountin…
Synthes, Inc.
T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Zimmer Biomet, Inc.
T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Diagnostic Hybrids, Inc.
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description …
Integra LifeSciences Corp.
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity corr…
Stryker GmbH
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Zimmer Biomet, Inc.
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textil…
Sofradim Production
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Roche Diagnostics Corporation
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Zimmer Biomet, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Smith & Nephew, Inc.
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquis…
Crimson Trace Corporation
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Zimmer Biomet, Inc.
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 2…
Covidien LLC
BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
Becton Dickinson & Company
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in…
Diagnostic Hybrids, Inc.
T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 2…
Covidien LLC
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Synthes, Inc.
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in rev…
Howmedica Osteonics Corp.
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Life Technologies Corporation
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental de…
Zimmer Biomet, Inc.
56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) D…
CooperVision Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Zimmer Biomet, Inc.
clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft …
CooperVision Inc.
56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) D…
CooperVision Inc.
BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
Becton Dickinson & Company
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
Zimmer Biomet, Inc.
T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
Stryker Instruments Div. of Stryker Corporation
MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The Mi…
Diagnostic Hybrids, Inc.
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.