Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 41 of 810
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Biomet, Inc.
Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
SEDECAL SA
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Acc…
Beckman Coulter, Inc.
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
SEDECAL SA
Model Number 40KWFXPLUS, Mobile X-ray system
SEDECAL SA
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA…
Synthes (USA) Products LLC
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
SEDECAL SA
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
SEDECAL SA
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
UIH Technologies LLC
Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
SEDECAL SA
Model Number 40KWFX, Mobile X-ray system
SEDECAL SA
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
Becton Dickinson & Co.
Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
SEDECAL SA
Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
SEDECAL SA
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Becton Dickinson & Co.
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
HeartSine Technologies Ltd
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended…
Home Health US, Incorporated
Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Sa…
Cardinal Health 200, LLC
Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
SEDECAL SA
Scepter Fuel Containers Recalled Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for P…
Scepter, of Canada
Scepter Fuel Containers Recalled Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for P…
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Baxter Healthcare Corporation
Model Number L211 PROPONENT DR SL MRI Pacemaker
Boston Scientific Corporation
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Olympus Corporation of the Americas
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-i…
Baxter Healthcare Corporation
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANG…
American Contract Systems Inc.
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
GE Medical Systems, LLC
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Olympus Corporation of the Americas
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott
Model Number U128, VALITUDE CRT-P EL MRI
Boston Scientific Corporation
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Olympus Corporation of the Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Olympus Corporation of the Americas
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch…
Baxter Healthcare Corporation
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Ferno-Washington Inc
Model Number L231, PROPONENT DR EL MRI Pacemaker
Boston Scientific Corporation
TENACIO Pump without InhibiZone; UPN: 72404420;
Boston Scientific Corporation
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Olympus Corporation of the Americas
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18…
BioPro, Inc.
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Ethicon Endo-Surgery Inc
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Olympus Corporation of the Americas
Model Number L101, ESSENTIO DR SL Pacemaker
Boston Scientific Corporation
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17A…
American Contract Systems Inc.
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 21248…
American Contract Systems Inc.
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimete…
Baxter Healthcare Corporation
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Olympus Corporation of the Americas
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 Jun 3, 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 Jun 3, 2026.