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 · 2026-08-23
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 479 of 819
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA universal and Endo GIA …
COVIDIEN MEDTRONIC
Prolia 60 mg/1 mL PF syringe NDC 55513-0710-01 180 days supply.
Kroger Specialty Pharmacy, Inc.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLi…
Vyaire Medical
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
Siemens Healthcare Diagnostics, Inc.
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture …
Boston Scientific Corporation
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Product Usage: The AirLife Resuscitation devices are manua…
Vyaire Medical
Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound hea…
Integra LifeSciences Corp.
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Synthes (USA) Products LLC
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Straumann Manufacturing, Inc.
IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
Siemens Healthcare Diagnostics, Inc.
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Datascope Corporation
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Datascope Corporation
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using…
TP Orthodontics, Inc.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitatio…
Vyaire Medical
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, inductio…
Draeger Medical, Inc.
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
DePuy Orthopaedics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
Siemens Healthcare Diagnostics, Inc.
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to a…
Boston Scientific Corporation
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
Datascope Corporation
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitatio…
Vyaire Medical
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Bard Peripheral Vascular Inc
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Datascope Corporation
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (al…
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
Siemens Healthcare Diagnostics, Inc.
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Bard Peripheral Vascular Inc
ADVIA Centaur¿ DHEA-SO4
Siemens Healthcare Diagnostics, Inc.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Zimmer Biomet, Inc.
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Bard Peripheral Vascular Inc
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with ma…
Baxter Healthcare Corporation
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Straumann Manufacturing, Inc.
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Bard Peripheral Vascular Inc
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blo…
Transonic Systems Inc
Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Beaver-Visitec International Inc.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid re…
Cook Inc.
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Siemens Healthcare Diagnostics, Inc.
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended…
Siemens Medical Solutions USA, Inc
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Mako Surgical Corporation
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reser…
Cook Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
Siemens Healthcare Diagnostics, Inc.
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Siemens Healthcare Diagnostics, Inc.
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Siemens Healthcare Diagnostics, Inc.
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Boston Scientific Corporation
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are man…
Vyaire Medical
BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
Datascope Corporation
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA…
Siemens Healthcare Diagnostics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
DePuy Orthopaedics, Inc.
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Datascope Corporation
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Siemens Healthcare Diagnostics, Inc.
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Datascope Corporation
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, Ig…
Hyphen BioMed
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.