Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- 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 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 90 of 808
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
Maquet Cardiovascular, LLC
smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
Smiths Medical ASD, Inc.
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Versi…
Olympus Corporation of the Americas
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Hobbs Medical, Inc.
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUE…
Bard Peripheral Vascular Inc
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Baxter Healthcare Corporation
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Caire, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Hobbs Medical, Inc.
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists …
Novosource, LLC
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Abbott Medical
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Caire, Inc.
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Caire, Inc.
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each process…
Siemens Healthcare Diagnostics, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Hobbs Medical, Inc.
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 300…
ICU Medical, Inc.
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Biomet, Inc.
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Hobbs Medical, Inc.
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Cook Incorporated
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but n…
ETHICON, INC.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
Baxter Healthcare Corporation
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
Baxter Healthcare Corporation
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GR…
Alcon Research LLC
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
Baxter Healthcare Corporation
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is …
OrganOx Ltd
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalab…
Philips Medical Systems Technologies Ltd.
Acrobat-i Positioner. Model Number C-XP-5000Z
Maquet Cardiovascular, LLC
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventio…
Getinge Usa Sales Inc
Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
AVID Medical, Inc.
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and…
Stryker Corporation
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Boston Scientific Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutt…
Stryker Corporation
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Boston Scientific Corporation
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths…
Olympus Corporation of the Americas
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
AVID Medical, Inc.
Lab Kit, SKU DYLAB1018; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
AVID Medical, Inc.
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting…
Stryker Corporation
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV)…
The Metrix Company
Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
AVID Medical, Inc.
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
AVID Medical, Inc.
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
AVID Medical, Inc.
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein i…
Bard Peripheral Vascular Inc
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
AVID Medical, Inc.
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV)…
The Metrix Company
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
AVID Medical, Inc.
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including …
Stryker Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Baxter Healthcare Corporation
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 2, 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 2, 2026.