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 330 of 819
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determinati…
RANDOX LABORATORIES, LTD.
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or m…
TELEFLEX MEDICAL INC
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitativ…
Becton Dickinson & Co.
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Smiths Medical ASD Inc.
Kasugai brand Matcha Ame (Green tea candy); 4.58 oz. plastic bag; 2 x 12 individual items per case Product of Japan Ingredients: glucose syrup, …
J F C International Inc
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver …
Ion Beam Applications S.A.
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the pos…
OrthoPediatrics Corp
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomic…
Medtronic Navigation, Inc.
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility…
Hill-Rom, Inc.
MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as cran…
Synthes Produktions GmbH
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of t…
Shanghai United Imaging Healthcare Co., Ltd.
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visual…
TELEFLEX MEDICAL INC
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for end…
Medline Industries Inc
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designe…
Richard Wolf GmbH
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedu…
Smith & Nephew, Inc.
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemicall…
Resource Optimization & Innovation LLC
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or i…
Arthrex, Inc.
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of t…
Shanghai United Imaging Healthcare Co., Ltd.
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualiza…
TELEFLEX MEDICAL INC
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as cranio…
Synthes, Inc.
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Abbott Gmbh & Co. KG
TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with imm…
Hill-Rom, Inc.
TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotrache…
Medline Industries Inc
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of t…
Shanghai United Imaging Healthcare Co., Ltd.
TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
Chengdu Ai Qin E-commerce Co., Ltd
Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visuali…
TELEFLEX MEDICAL INC
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators …
Steris Corporation
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intend…
Boston Scientific Corporation
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablatio…
Boston Scientific Corporation
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Carefusion 2200 Inc
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 0080…
Becton Dickinson & Company
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended f…
Boston Scientific Corporation
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Becton Dickinson & Company
PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343…
Becton Dickinson & Company
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG …
Becton Dickinson & Company
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505)…
Becton Dickinson & Company
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA0…
Becton Dickinson & Company
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231)…
Becton Dickinson & Company
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.