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 233 of 819
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
Mckesson Medical-Surgical Inc. Corporate Office
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedu…
Surgical Innovations Ltd
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
Mckesson Medical-Surgical Inc. Corporate Office
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Cook Incorporated
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) …
Mckesson Medical-Surgical Inc. Corporate Office
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify Si…
Mckesson Medical-Surgical Inc. Corporate Office
Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.
Mckesson Medical-Surgical Inc. Corporate Office
a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKess…
Mckesson Medical-Surgical Inc. Corporate Office
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691)…
Cook Incorporated
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL S…
Mckesson Medical-Surgical Inc. Corporate Office
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Cont…
Tandem Diabetes Care Inc
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopi…
Olympus Corporation of the Americas
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson…
Mckesson Medical-Surgical Inc. Corporate Office
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Cook Incorporated
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Cook Incorporated
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Cook Incorporated
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621…
Cook Incorporated
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Cook Incorporated
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Leica Microsystems, Inc.
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Howmedica Osteonics Corp.
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labele…
MEDLINE INDUSTRIES, LP - Northfield
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
Cook Incorporated
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 …
Cook Incorporated
a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET FLUSHABLE ADULT 9X13" (24/PK 24PK/C…
Mckesson Medical-Surgical Inc. Corporate Office
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Ca…
Mckesson Medical-Surgical Inc. Corporate Office
a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
Mckesson Medical-Surgical Inc. Corporate Office
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Siemens Healthcare Diagnostics, Inc.
a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petr…
Mckesson Medical-Surgical Inc. Corporate Office
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Leica Microsystems, Inc.
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). …
MEDLINE INDUSTRIES, LP - Northfield
MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14FR Model Number: 884450023358. Used to secure anaesthesia catheter.
Mckesson Medical-Surgical Inc. Corporate Office
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopi…
Olympus Corporation of the Americas
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
Ossur Americas
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
SunMed Holdings, LLC
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
DICOM Grid, Inc. d/b/a Ambra Health
a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT …
Mckesson Medical-Surgical Inc. Corporate Office
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
Cook Incorporated
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Siemens Healthcare Diagnostics, Inc.
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of va…
Angiodynamics, Inc.
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS M…
Mckesson Medical-Surgical Inc. Corporate Office
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
MALVERN PANALYTICAL LTD
Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopi…
Olympus Corporation of the Americas
MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labele…
MEDLINE INDUSTRIES, LP - Northfield
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18…
Cook Incorporated
a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQU…
Mckesson Medical-Surgical Inc. Corporate Office
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
BARCO NV
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
CAREFUSION
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
CAREFUSION
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
CAREFUSION
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.