Hazard

Surgical Intervention recalls

29 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 29
Critical: 0
Severe: 21
Most recent: 2026-08-12

Of the 29 surgical intervention recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (72%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all surgical intervention recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 29

SevereFDA (Devices)·Z-2879-2026·2026-08-12
Boston Scientific Spinal Cord Stimulator Lead Kits Recalled
Boston Scientific is recalling INFINION CX LEAD KITs (50cm and 70cm) used in spinal cord stimulator systems due to potential lead body stress at the anchor site, which may cause lead fractures or high impedance and result in inadequate stimulation or need for additional surgery.
Product
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1072-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 483 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1076-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems Due to Sheath Separation
Argon Medical Devices is recalling 1,759 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1075-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 247 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1073-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 863 TLAB Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1077-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 583 Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1074-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy System Due to Sheath Separation
Argon Medical Devices is recalling the TLAB Transjugular Liver Biopsy System because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0561-2020·2020-01-01
LivaNova SenTiva VNS Therapy Generators Recalled for Potential Device Reset
LivaNova is recalling SenTiva VNS Therapy generators that may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing a return of symptoms.
Product
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-2265-2019·2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than bloo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2261-2019·2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2260-2019·2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from b
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2264-2019·2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2267-2019·2019-08-21
Smith & Nephew Wound Drain Recall Due to Breakage Risk
Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.
Product
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain flu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2266-2019·2019-08-21
Medline Silicone Drain Recalled for Risk of Breaking During Use
Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2262-2019·2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2263-2019·2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, dr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2019·2019-06-26
Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Safety Lock Knob
Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts that may contain a damaged gray safety lock knob, which could prevent full deployment of the graft.
Product
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84,
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1687-2019·2019-06-05
Abbott MitraClip XTR Clip Delivery System Recalled for Malfunction
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
Product
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Category
Medical Device
Distribution
49 states
SevereFDA (Devices)·Z-0754-2019·2019-01-30
Teleflex Percuvance Percutaneous Shaft Recall Due to Tip Breakage Risk
Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.
Product
Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver He
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0753-2019·2019-01-30
Teleflex Percuvance Percutaneous Shaft Recall for Potential Tip Breakage
Teleflex Medical is recalling Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially compromising the tool's security.
Product
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2369-2018·2018-07-11
Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging. The residue is a mix of titanium and polyethylene.
Product
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2368-2018·2018-07-11
Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling 510 M/L Taper Hip Prostheses distributed to Japan due to potential black residue in the packaging.
Product
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2364-2018·2018-07-11
Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The firm states the residue is biocompatible.
Product
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2367-2018·2018-07-11
Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
Zimmer Biomet is recalling 84 M/L Taper Hip Prostheses with Kinective Technology due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.
Product
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2362-2018·2018-07-11
Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging
Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging bags.
Product
Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Category
Medical Device
Distribution
0 states