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
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 210 of 819
Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
MEDLINE INDUSTRIES, LP - Northfield
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc.
Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
MEDLINE INDUSTRIES, LP - Northfield
iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Conformis, Inc.
Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJ…
MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489
MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
MEDLINE INDUSTRIES, LP - Northfield
Orthex Large Bone Shoulder Bolt, model no. AS-17
OrthoPediatrics Corp
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
MicroPort Orthopedics Inc.
Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder N…
MEDLINE INDUSTRIES, LP - Northfield
Skinny Dipped Dark Chocolate Salted Caramel Cashews, 3.5 oz, packaged in flexible plastic pouches inside cardboard cases. Ingredients: Cashews, Dark …
SKINNY DIPPED
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS B…
MEDLINE INDUSTRIES, LP - Northfield
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Quest Medical, Inc.
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH…
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO…
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PAC…
MEDLINE INDUSTRIES, LP - Northfield
HIGH V+ Spinal Cement System REF T040321K
TEKNIMED SAS
Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF …
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GEN…
MEDLINE INDUSTRIES, LP - Northfield
LOCAL PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
MEDLINE INDUSTRIES, LP - Northfield
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-0800…
Wishbone Medical, Inc.
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK…
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
MEDLINE INDUSTRIES, LP - Northfield
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner …
Bard Peripheral Vascular Inc
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Owens & Minor Distribution, Inc.
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
MEDLINE INDUSTRIES, LP - Northfield
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
NuVasive Inc
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJ…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
RipCord Syndesmosis Button, REF: STA001K
TriMed Inc.
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. OR…
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH V…
MEDLINE INDUSTRIES, LP - Northfield
GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, …
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
MEDLINE INDUSTRIES, LP - Northfield
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) …
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLA…
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DE…
MEDLINE INDUSTRIES, LP - Northfield
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Roche Molecular Systems, Inc.
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f.…
MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: LS MS PACK
MEDLINE INDUSTRIES, LP - Northfield
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inc…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
MEDLINE INDUSTRIES, LP - Northfield
TRACH PACK. Sterile Procedural Tray.
MEDLINE INDUSTRIES, LP - Northfield
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.