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 208 of 819
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood …
Stryker Corporation
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 …
Covidien, LP
Ultracell Wick with 80cc Collection Bag, 20/box
Beaver Visitec International, Inc.
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture …
Biomerieux Inc
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II …
Covidien, LP
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision, Inc.
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Baxter Healthcare Corporation
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL IN…
Encore Medical, LP
Phoenix mKDR, digital mobile diagnostic x-ray system
SEDECAL SA
Sit to Stand STS500 Patient Lift
Med-Mizer, Inc.
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Baxter Healthcare Corporation
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-…
Covidien, LP
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood …
Stryker Corporation
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a cor…
Stryker GmbH
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Unetixs Vascular, Inc.
Med-Riser MR600 Patient Lift
Med-Mizer, Inc.
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Wright Medical Technology, Inc.
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 …
Covidien, LP
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Unetixs Vascular, Inc.
CustomEyes kits
Beaver Visitec International, Inc.
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Baxter Healthcare Corporation
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-82…
Covidien, LP
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Siemens Medical Solutions USA, Inc
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous the…
Access Vascular, Inc
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Cardinal Health 200, LLC
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Siemens Medical Solutions USA, Inc
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Draeger Medical, Inc.
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000…
Hologic, Inc.
Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Cardinal Health 200, LLC
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens…
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e an…
Siemens Healthcare Diagnostics, Inc.
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Si…
Siemens Healthcare Diagnostics, Inc.
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
Siemens Medical Solutions USA, Inc
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Draeger Medical, Inc.
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and …
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with…
MEDLINE INDUSTRIES, LP - Northfield
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous ther…
Access Vascular, Inc
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Siemens Medical Solutions USA, Inc
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Siemens Medical Solutions USA, Inc
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN…
MEDLINE INDUSTRIES, LP - Northfield
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Cardinal Health 200, LLC
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemen…
Siemens Healthcare Diagnostics, Inc.
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask…
S & MOHR AMERICA, S.A. DE C.V.
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens…
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. …
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Sieme…
Siemens Healthcare Diagnostics, Inc.
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx o…
Sentara Infusion Services
VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independ…
Sentara Infusion Services
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, us…
Sentara Infusion Services
TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1…
Sentara Infusion Services
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.