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 214 of 819
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
Medtronic Neuromodulation
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Stradis Healthcare
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Stradis Healthcare
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Stradis Healthcare
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Stradis Healthcare
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-…
International Medical Industries, Inc.
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal Industries Inc
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Medtronic Navigation, Inc.
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VE…
Ventana Medical Systems, Inc.
BD Pyxis MedBank System - Product Label/labeling pending
CareFusion 303, Inc.
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including t…
The Anspach Effort, Inc.
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804…
Philips Respironics, Inc.
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone i…
The Anspach Effort, Inc.
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shap…
The Anspach Effort, Inc.
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone in…
The Anspach Effort, Inc.
BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 5463…
Depuy Ireland UC
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; …
MEDLINE INDUSTRIES, LP - Northfield
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
The Anspach Effort, Inc.
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621…
Bayer Medical Care, Inc.
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyrogl…
Siemens Healthcare Diagnostics, Inc.
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Philips North America Llc
Philips Garbin Ventilator, Model Number 1058180B
Philips Respironics, Inc.
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Medtronic Neuromodulation
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Stradis Healthcare
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Stradis Healthcare
PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Biomerieux Inc
VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
Biomerieux Inc
VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
Biomerieux Inc
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
Biomerieux Inc
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack …
Windstone Medical Packaging, Inc.
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Biomerieux Inc
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Biomerieux Inc
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Biomerieux Inc
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Biomerieux Inc
BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012
Biomerieux Inc
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Biomerieux Inc
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
Biomerieux Inc
ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
Biomerieux Inc
ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
Biomerieux Inc
VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
Biomerieux Inc
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
Biomerieux Inc
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Biomerieux Inc
VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
Biomerieux Inc
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Biomerieux Inc
VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
Biomerieux Inc
ActiveAid 922, Shower/Commode Chair
Altimate Medical, Inc.
VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051
Biomerieux Inc
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
Biomerieux Inc
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
Biomerieux Inc
PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
Biomerieux 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.