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 394 of 819
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where …
Aesculap Implant Systems LLC
XP-XP Tibial Tray - Interlok 91mm Item # 195761
Zimmer Biomet, Inc.
Humanscale Recalls QuickStand Lite Workstations Due to Injury Hazard
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
OMNIlife science Inc.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Roche Diagnostics Operations, Inc.
CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
B. Braun Medical, Inc.
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single…
LeMaitre Vascular, Inc.
ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
B. Braun Medical, Inc.
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Stryker Communications
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Becton Dickinson & Co.
HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the …
Haag-Streit USA Inc
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definit…
Siemens Medical Solutions USA, Inc
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Coltene /Whaledent AG
CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
B. Braun Medical, Inc.
HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modu…
Haag-Streit USA Inc
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum…
Roche Diagnostics Operations, Inc.
CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
B. Braun Medical, Inc.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Helena Laboratories, Inc.
cobas c513 Analyzer
Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 …
Roche Diagnostics Operations, Inc.
SonarMed AirWave Monitor, Model Number M0001
SonarMed Inc
CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
B. Braun Medical, Inc.
CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
B. Braun Medical, Inc.
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Becton Dickinson & Co.
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Chol…
Alere San Diego, Inc.
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modu…
Haag-Streit USA Inc
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Integra LifeSciences Corp.
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Boston Scientific Corporation
Norm-O-Temp model 111Z
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Flexible Intubation Fiberscope, Model # 11301AB1
Karl Storz Endoscopy
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5…
OMNIlife science Inc.
Fujifilm FDR Go Plus mobile X-ray system
Fujifilm Medical Systems U.S.A., Inc.
Norm-O-Temp model 111W
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
GETINGE US SALES LLC
CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
B. Braun Medical, Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
OMNIlife science Inc.
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
CareFusion 303, Inc.
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Angiodynamics, Inc.
FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
B. Braun Medical, Inc.
ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
B. Braun Medical, Inc.
SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
Heidelberg Engineering GmbH
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally in…
Stryker GmbH
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310
Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327
Bard Peripheral Vascular Inc
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimal…
Stryker GmbH
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334
Bard Peripheral Vascular Inc
EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
Bard Peripheral Vascular 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.