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 223 of 819
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
ARROW INTERNATIONAL Inc.
DeRoyal BASIC EYE PACK, REF 89-8337.09
DeRoyal Industries Inc
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
ARROW INTERNATIONAL Inc.
DeRoyal NEURO PACK, REF 89-9253.09
DeRoyal Industries Inc
Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
ConMed Corporation
DeRoyal NEURO PACK, REF 89-10682.02
DeRoyal Industries Inc
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
DeRoyal Industries Inc
DeRoyal TOTAL HIP KIT, REF 89-9498.08
DeRoyal Industries Inc
STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
Stradis Medical, LLC dba Stradis Healthcare
DeRoyal HEART PACK, REF 89-8351.11
DeRoyal Industries Inc
DeRoyal SHOULDER PACK, REF 89-6830.13
DeRoyal Industries Inc
DeRoyal ENDOVENOUS PACK, REF 89-7762.05
DeRoyal Industries Inc
STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
Stradis Medical, LLC dba Stradis Healthcare
DeRoyal CUSTOM NEURO PACK, REF 89-8392.09
DeRoyal Industries Inc
DeRoyal BIOPSY PACK, REF 89-9270.05
DeRoyal Industries Inc
DeRoyal BASIC NEURO PACK, REF 89-7258.13
DeRoyal Industries Inc
DeRoyal EYE PACK, REF 89-4051.09
DeRoyal Industries Inc
DeRoyal CATARACT PACK, REF 89-10086.05
DeRoyal Industries Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
ARROW INTERNATIONAL Inc.
DeRoyal LAPINECTOMY PACK, REF 89-7198.10
DeRoyal Industries Inc
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Leica Microsystems, Inc.
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
DeRoyal Industries Inc
STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
Stradis Medical, LLC dba Stradis Healthcare
DeRoyal NEURO PACK, REF 89-10171.06
DeRoyal Industries Inc
HENRY SCHEIN, BREAST PACK, Item No.570-2397
Stradis Medical, LLC dba Stradis Healthcare
DeRoyal CRANI PACK, REF 89-10242.04
DeRoyal Industries Inc
HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
Stradis Medical, LLC dba Stradis Healthcare
Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
Carefusion 2200 Inc
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
Carefusion 2200 Inc
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
DEWEI MEDICAL EQUIPMENT CO LTD
Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
Carefusion 2200 Inc
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Philips North America Llc
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
Carefusion 2200 Inc
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (o…
Medical Action Industries, Inc. 306
CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126
Carefusion 2200 Inc
Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
Carefusion 2200 Inc
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Remel Inc
Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
Carefusion 2200 Inc
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
Remel Inc
CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006
Carefusion 2200 Inc
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of…
Cardinal Health
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
Carefusion 2200 Inc
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Randox Laboratories Ltd.
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
Caire, Inc.
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125
Carefusion 2200 Inc
CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014
Carefusion 2200 Inc
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Remel 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.