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 · 2026-08-25
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 541 of 819
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the …
Merge Healthcare, Inc.
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy …
Breg Inc
eMax2 Hybrid Hand Control Product Usage: Electric system
The Anspach Effort, Inc.
Compact Speed Reducer, 60:1 Black Max
The Anspach Effort, Inc.
Electronic Foot Control with Direction Switch Product Usage: Electric system
The Anspach Effort, Inc.
10.5cm QD Angle Attachment Product Usage: Pneumatic system
The Anspach Effort, Inc.
IMRI MOTOR Product Usage: Pneumatic system
The Anspach Effort, Inc.
Foot Control, SC2100 Product Usage: Electric system
The Anspach Effort, Inc.
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available …
Roche Diabetes Care, Inc.
22CM MICRO REVISION ATTACH, BLACK MAX
The Anspach Effort, Inc.
Autolube-III with NK Product Usage: Pneumatic system
The Anspach Effort, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Smith & Nephew, Inc.
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
The Anspach Effort, Inc.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in…
Beckman Coulter Inc.
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is…
Zimmer Trabecular Metal Technology, Inc.
AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
The Anspach Effort, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
Smith & Nephew, Inc.
Adult Craniotome Product Usage: Pneumatic system
The Anspach Effort, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
Smith & Nephew, Inc.
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
Smith & Nephew, Inc.
20.2cm Heavy Duty Long Heavy Short Attachment
The Anspach Effort, Inc.
5.0cm Heavy Duty Short Attachment
The Anspach Effort, Inc.
Sagittal MICRO-SAW
The Anspach Effort, Inc.
XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
The Anspach Effort, Inc.
Pediatric Craniotome
The Anspach Effort, Inc.
14cm QD Angle Attachment
The Anspach Effort, Inc.
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care…
Breg Inc
Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of …
Dale Medical Products, Inc.
Oscillating MICRO-SAW Product Usage: Pneumatic system
The Anspach Effort, Inc.
8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
The Anspach Effort, Inc.
16.5CM MICRO REVISION ATTACH, BLACK MAX
The Anspach Effort, Inc.
LARGE CRANIOTOME, BLACK MAX
The Anspach Effort, Inc.
KEYLESS DRIVER, BLACK MAX
The Anspach Effort, Inc.
10.5CM ANGLE ATTACHMENT, BLACK MAX
The Anspach Effort, Inc.
11.25CM ATTACHMENT, BLACK MAX
The Anspach Effort, Inc.
8CM ANGLE ATTACHMENT, BLACK MAX
The Anspach Effort, Inc.
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous …
Newport Medical Instruments Inc
7.2cm Adjustable Drill Guide Product Usage: Electric system
The Anspach Effort, Inc.
B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
The Anspach Effort, Inc.
Minimal Access Straight Driver Product Usage: Pneumatic system
The Anspach Effort, Inc.
SMALL ATTACHMENT, JACOBS CHUCK
The Anspach Effort, Inc.
Chuck Driver System
The Anspach Effort, Inc.
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autocl…
Olympus Corporation of the Americas
Console, eMax2 Plus Product Usage: Electric system
The Anspach Effort, Inc.
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Smith & Nephew, Inc.
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
Smith & Nephew, Inc.
19CM ATTACHMENT, BLACK MAX
The Anspach Effort, Inc.
Sagittal Saw Product Usage: Pneumatic system
The Anspach Effort, Inc.
Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system
The Anspach Effort, 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.