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 393 of 819
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering …
Philips North America, LLC
XP-CR Tibial Tray - Interlok 91 mm Item # 195279
Zimmer Biomet, Inc.
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage:…
Allergan PLC
Vanguard XP Tibial Tray 79 mm Item # 195252
Zimmer Biomet, Inc.
Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized…
Stryker Communications
Vanguard XP Tibial Tray 67 mm Item # 195247
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 83 mm Item # 195277
Zimmer Biomet, Inc.
ROTEM ex-tem; US Part No: 503-05-US
Instrumentation Laboratory Co.
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitorin…
Philips North America, LLC
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized…
Stryker Communications
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-…
Teleflex Medical
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmen…
Allergan PLC
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
Zimmer Biomet, Inc.
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL…
Allergan PLC
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-104…
Teleflex Medical
Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Br…
Allergan PLC
Vanguard XP Tibial Tray 65 mm Item # 195246
Zimmer Biomet, Inc.
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, increme…
Allergan PLC
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Teleflex Medical
XP-CR Tibial Tray - Interlok 63mm Item # 195269
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 67 mm Item # 195753
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 69 mm Item # 195248
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 71mm Item # 195273
Zimmer Biomet, Inc.
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Trache…
Teleflex Medical
XP-CR Tibial Tray - Interlok 65mm Item # 195270
Zimmer Biomet, Inc.
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where…
Aesculap Implant Systems LLC
XP-CR Tibial Tray - Interlok 73mm Item # 195274
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 79 mm Item # 195276
Zimmer Biomet, Inc.
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110…
Allergan PLC
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T…
Allergan PLC
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 71 mm Item # 195249
Zimmer Biomet, Inc.
XP-XP Tibial Tray - Interlok 71 mm Item # 195755
Zimmer Biomet, Inc.
XP- CR Tibial Tray- Interlok 59mm Item # 195268
Zimmer Biomet, Inc.
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Proje…
Allergan PLC
Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style …
Allergan PLC
Vanguard XP Tibial Tray 87 mm Item # 195254
Zimmer Biomet, Inc.
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Teleflex Medical
Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
Allergan PLC
McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
Allergan PLC
XP-XP Tibial Tray - Interlok 87 mm Item # 195760
Zimmer Biomet, Inc.
XP-CR Tibial Tray - Interlok 67mm Item # 195271
Zimmer Biomet, Inc.
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional…
Exactech, Inc.
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analy…
Randox Laboratories Ltd.
Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepCl…
Zeus Scientific, Inc.
XP-CR Tibial Tray - Interlok 69mm Item # 195272
Zimmer Biomet, Inc.
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Vanguard XP Tibial Tray 83 mm Item # 195253
Zimmer Biomet, Inc.
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast recons…
Allergan PLC
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.