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 796 of 822
18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass sur…
Terumo Cardiovascular Systems Corporation
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 …
iwalk inc
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX …
Extremity Medical LLC
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distribut…
Parks Medical Electronics, Inc
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration …
Iradimed Corporation
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparo…
Cooper Surgical, Inc.
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extrac…
Terumo Cardiovascular Systems Corporation
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is…
Medtronic Navigation, Inc.
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22O…
GE Healthcare, LLC
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extrac…
Terumo Cardiovascular Systems Corporation
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oam…
GE Healthcare, LLC
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection a…
Diamedix Corporation
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22O…
GE Healthcare, LLC
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses.…
Zimmer, Inc.
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy …
Cooper Surgical, Inc.
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerativ…
Biomet, Inc.
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlli…
Kimberly-Clark Corporation
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and health…
Metrex Research, LLC.
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenou…
First Medical Source LLC
Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3…
Church & Dwight Inc
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for …
Microgenics Corporation
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, in diffusely…
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines, in diffuse…
Superstat Corp
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare, LLC
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provision…
Zimmer, Inc.
bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazili…
Biomerieux Inc
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intend…
Horiba Instruments, Inc dba Horiba Medical
bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Softw…
Biomerieux Inc
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70k…
King Systems Corp.
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Vital Signs Colorado Inc.
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50k…
King Systems Corp.
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along suture lines, in…
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines, in diffuse…
Superstat Corp
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 S…
Biomerieux Inc
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 …
Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 So…
Biomerieux Inc
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: L…
King Systems Corp.
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, in diffusely…
Superstat Corp
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 So…
Biomerieux Inc
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 S…
Zimmer, Inc.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic de…
Beckman Coulter Inc.
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
NuVasive Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 …
Biomerieux Inc
CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixati…
Captiva Spine, Inc
SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specia…
Stryker Spine
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.