Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 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 136 of 808
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applic…
Qiagen Sciences LLC
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/…
ConvaTec, Inc
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-00…
Synovo Production
Chromophare Surgical Light System , REF CH00000001
Stryker Communications
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE…
Baxter Healthcare Corporation
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Human Care Hc Sweden Ab
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients wh…
Boston Scientific Corporation
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who …
Boston Scientific Corporation
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Microbiologics Inc
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Intuitive Surgical, Inc.
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are un…
Boston Scientific Corporation
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unab…
Boston Scientific Corporation
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-…
Synovo Production
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
MEDLINE INDUSTRIES, LP - Northfield
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 7…
Baxter Healthcare Corporation
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPO…
Baxter Healthcare Corporation
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-516…
Synovo Production
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional…
Philips North America
Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MD…
MEDLINE INDUSTRIES, LP - Northfield
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
RAYSEARCH LABORATORIES AB
Hemostasis Probe, Model: CD-B622LA
Olympus Corporation of the Americas
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314…
Exactech, Inc.
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Prod…
MEDLINE INDUSTRIES, LP - Northfield
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Covidien, LP
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
MEDLINE INDUSTRIES, LP - Northfield
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic …
Life Technologies Corporation
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Karl Storz Endoscopy
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Abbott GmbH
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
MEDLINE INDUSTRIES, LP - Northfield
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
SleepNet Corporation
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code …
MEDLINE INDUSTRIES, LP - Northfield
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 4…
Exactech, Inc.
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
MEDLINE INDUSTRIES, LP - Northfield
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Exactech, Inc.
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
O&M HALYARD, INC.
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthropl…
Exactech, Inc.
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Lar…
Exactech, Inc.
iQ 2 Nasal Vented Mask
SleepNet Corporation
Mojo 2 Full Face Non Vented Mask, All Sizes
SleepNet Corporation
MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
MEDLINE INDUSTRIES, LP - Northfield
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44,…
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-…
Exactech, Inc.
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure in…
Baxter Healthcare Corporation
Centurion STERILE #16 RUBBER BAND, Product Code EB16
MEDLINE INDUSTRIES, LP - Northfield
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Abbott Laboratories
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Karl Storz Endoscopy
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product …
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 2, 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 2, 2026.