Product category · Updated Jul 29, 2026

Medical Devices recalls

Name: Medical Devices Recalls
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls: 40,910
Top agency: FDA Devices
Years covered: 2000–2026

Compiled from official public sources by the editorial process. · Updated August 2026

Check a product → All categories

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

High severity

3,645
Moderate

36,211
Lower severity

1,054

FDA Devices

39,635
FDA Drug

934
CPSC

306
FDA Food

35

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 222 of 819

FDA Devices Moderate Dec 21, 2022

Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

Cordis US Corp

FDA Devices Moderate Dec 21, 2022

Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, …

ARROW INTERNATIONAL Inc.

FDA Devices Moderate Dec 21, 2022

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in ped…

Ethicon, Inc.

FDA Devices Moderate Dec 21, 2022

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 21, 2022

Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 2022

DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05

DeRoyal Industries 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.

Compiled by PlainRecalls, Product Recalls Editorial Process · August 12, 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.

Recalls in Medical Devices

STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS

GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09

DeRoyal MAJOR ORTHO PACK, REF 89-9250.07

Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

DeRoyal EYE PACK, REF 89-8756.03

DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07

STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray

STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,

DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07

DeRoyal KIT HEART B PACK, REF 89-9042.08

DeRoyal EYE TRAY PGYBK, REF 89-7978.02

DeRoyal NEURO PACK, REF 89-10171.05

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump

DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03

DeRoyal TOTAL HIP KIT, REF 89-9498.10

Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, …

DeRoyal TOTAL HIP PACK, REF 89-9301.07

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02

STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray

STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,

STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,

HENRY SCHEIN, GYN PACK, Item No.570-2625

PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in ped…

DeRoyal CATARACT PACK, REF 89-7135.10

DeRoyal CUSTOM NEURO PACK, REF 89-8392.10

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

DeRoyal SPINE PACK, REF 89-8361.10

STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,

DeRoyal PACEMAKER ICD PACK, REF 89-10216.03

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump

DeRoyal GU ROBOTIC PACK, REF 89-7063.12

GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01

DeRoyal BREAST TRAY, REF 89-7033.07

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump

DeRoyal BASIC NEURO PACK, REF 89-7258.12

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump

DeRoyal BASIC EYE PACK, REF 89-8337.08

DeRoyal SHOULDER KIT, REF 89-9497.10

DeRoyal GU PACK, REF 89-10665.02

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump

DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12

STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,

DeRoyal BASIC PACK, REF 89-8633.07

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump

HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072

NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative…

Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP

DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05

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Data sources