Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 54 of 810
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
AVID Medical, Inc.
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is indiv…
Nuclein LLC
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U …
Flexicare Medical (Dongguan) Ltd.
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Beckman Coulter, Inc.
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
DRG International, Inc.
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Intersurgical Inc
HVI CARDIAC ROBOT PACK. Medical convenience kit.
AVID Medical, Inc.
GENERAL ROBOTIC PACK. Medical convenience kit.
AVID Medical, Inc.
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Intersurgical Inc
CARDIAC ROBOT PACK. Medical convenience kit.
AVID Medical, Inc.
DAVINCI UROLOGY. Medical convenience kit.
AVID Medical, Inc.
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-…
Stryker Corporation
GS ENDOSCOPY PACK. Medical convenience kit.
AVID Medical, Inc.
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Flexicare Medical (Dongguan) Ltd.
CT DAVINCI. Medical convenience kit.
AVID Medical, Inc.
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Beckman Coulter, Inc.
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Philips Medical Systems (Cleveland) Inc
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
CareFusion 303, Inc.
DA VINCI PACK URO/PROSTATE. Medical convenience kit.
AVID Medical, Inc.
Fieldsheer Apparel Technologies Recalls Heated Socks Due to Injury Hazard
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 1…
Pfizer Inc.
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 1…
Pfizer Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product …
Abiomed, Inc.
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare Diagnostics Inc
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Draeger, Inc.
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
Philips North America
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Fresenius Kabi USA, LLC
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Steris Corporation
BostonSight SCLERAL Lens
Boston Foundation For Sight
BostonSight PROSE Lens.
Boston Foundation For Sight
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Remel, Inc
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Steris Corporation
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Philips North America
3M Ranger Irrigation Fluid Warming Set, REF 24750
3M Company
Ingenia 1.5T S Model Number (REF): 781347;
Philips North America
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Microbiologics Inc
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
Philips North America
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Draeger, Inc.
Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software …
Osteotec Limited
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Philips North America
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Philips North America
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounti…
Implant Direct Sybron Manufacturing LLC
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Philips North America
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Cels…
INSTITUT GEORGES LOPEZ
Upgrade to MR 7700 Model Number (REF): 782130;
Philips North America
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;
Philips North America
Blood/MacConkey Biplate 100/PK, Product Number R02049
Remel, Inc
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Phasor Health, LLC
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 v…
Hamilton Medical AG
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
Philips North America
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 Jun 3, 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 Jun 3, 2026.