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 · 2026-08-31
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 653 of 819
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an acce…
Medtronic Navigation, Inc.
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast medi…
Cook Inc.
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical …
Zimmer Surgical Inc
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / …
TITAN SPINE, LLC
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but n…
Siemens Medical Solutions USA, Inc
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
The Anspach Effort, Inc.
Biograph mCT Flow Edge-4R, Model Number 10528955
Siemens Medical Solutions USA Inc.
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named…
Merge Healthcare, Inc.
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instr…
Medtronic Navigation, Inc.
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Techn…
GE Healthcare
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S300…
Siemens Medical Solutions USA, Inc.
Biograph mCT X-4R, Model Number 10248670
Siemens Medical Solutions USA Inc.
18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professio…
Zimmer Surgical Inc
Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientif…
EXP Pharmaceutical Services Corp
ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Paragon Laboratory Management
McKesson Technologies, Inc.
ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; E…
EXP Pharmaceutical Services Corp
Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Bro…
Hardy Diagnostics
Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by comp…
Philips Medical Systems (Cleveland) Inc
Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valle…
EXP Pharmaceutical Services Corp
ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Musculoskeletal Transplant Foundation, Inc.
ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog…
EXP Pharmaceutical Services Corp
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25…
EXP Pharmaceutical Services Corp
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackage…
EXP Pharmaceutical Services Corp
ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer re…
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ra…
Philips Medical Systems (Cleveland) Inc
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP …
EXP Pharmaceutical Services Corp
Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Ag…
Hardy Diagnostics
Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with…
Hardy Diagnostics
Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (O…
EXP Pharmaceutical Services Corp
Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Sutur…
EXP Pharmaceutical Services Corp
Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray trans…
Philips Medical Systems (Cleveland) Inc
Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey A…
Hardy Diagnostics
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager)…
EXP Pharmaceutical Services Corp
ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2…
Siemens Medical Solutions USA, Inc.
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
The Anspach Effort, Inc.
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Draeger Medical, Inc.
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings…
Otto Bock Healthcare GmbH
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.