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
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · NHTSA federal recall filings · 2026-08-24
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 488 of 819
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to…
Teleflex Medical Europe Ltd
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322…
Beckman Coulter Inc.
Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A
Arrow International Inc
Progressa Bed - AC-powered adjustable hospital bed
Hill-Rom, Inc.
ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123…
Arrow International Inc
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 15300002…
Teleflex Medical Europe Ltd
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicat…
Neuropro Spinal Jaxx
Normed Charcot Osteotome Chisel (Various sizes)
Zimmer GmbH
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Teleflex Medical Europe Ltd
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters …
The Magstim Company Limited
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Ki…
Terumo Cardiovascular Systems Corp
Doyen-Collin Mouth Gag 120MM/ General Instruments
Aesculap Implant Systems LLC
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2…
TriMed Inc.
First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 7…
Certified Safety Mfg Inc
(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Ven…
Arrow International Inc
Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position opht…
Reliance Medical Products Inc
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, fil…
Mindray DS USA, Inc. dba Mindray North America
(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial …
Arrow International Inc
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-2…
Arrow International Inc
7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San …
ICU Medical, Inc.
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Orthofix, Inc
(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with…
Arrow International Inc
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, …
ICU Medical, Inc.
Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be …
C.R. Bard, Inc.
AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectabl…
Arrow International Inc
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 80…
Beckman Coulter Inc.
Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
Arrow International Inc
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Gyrus ACMI, Inc.
Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are inten…
C.R. Bard, Inc.
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Lifeline Systems Company
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Hamilton Medical AG
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on th…
ICU Medical, Inc.
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
Arrow International Inc
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation…
Beckman Coulter Inc.
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Ethicon, Inc.
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Fresenius Medical Care Renal Therapies Group, LLC
Radial Artery Catheterization Kit; Model: AK-04220
Arrow International Inc
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham,…
The Binding Site Group, Ltd.
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Magellan Diagnostics, Inc.
Dynavox T10 Speech Generating Device ( including Batteries)
Dynavox Systems Llc
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Seiler Instr. & Mfg. Co. Inc.
Radial Artery Catheterization Kit; Model: AK-04020
Arrow International Inc
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Magellan Diagnostics, Inc.
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica…
GE Healthcare, LLC
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Zimmer Biomet, Inc.
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which …
GE Healthcare, LLC
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage…
C.R. Bard, Inc.
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use wi…
Southmedic, Inc.
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. T…
Phadia Ab
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDE…
DePuy Spine, 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.