Hazard

Surgical Kit recalls

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

What the numbers show

Total: 13
Critical: 0
Severe: 3
Most recent: 2026-04-15

Of the 13 surgical kit recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (23%) 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 kit 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.

1–13 of 13

SevereFDA (Devices)·Z-1730-2026·2026-04-15
Medline arthroscopy and extremity packs recalled over syringe adaptor unwinding
Medline is recalling Shoulder Arthroscopy and Extremity Pack convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1723-2026·2026-04-15
Medline minor plastic surgery packs recalled over syringe adaptor unwinding risk
Medline is recalling Minor Plastic-LF convenience kits containing NAMIC rotating adaptor control syringes because the adaptor can unwind during use and disconnect from the manifold.
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1722-2026·2026-04-15
Medline laparoscopic and minor procedure packs recalled over syringe adaptor defect
Medline is recalling laparoscopic herniorrhaphy, lap and minor procedure packs containing NAMIC rotating adaptor control syringes because the adaptor can unwind and disconnect during use.
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2530-2025·2025-09-17
ENT convenience packs recalled over open header bag seals compromising sterility
Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.
Product
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2465-2025·2025-09-03
Lap chole and laparoscopy packs recalled over unmet sterilization assurance requirements
American Contract Systems lap chole and laparoscopy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,233 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2467-2025·2025-09-03
Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components
American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2471-2025·2025-09-03
Hysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems robotic and vaginal hysterectomy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 50 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2468-2025·2025-09-03
Craniotomy and shunt packs recalled over unjustified sterilization of certain components
American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2472-2025·2025-09-03
Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2466-2025·2025-09-03
Cystoscopy and TUR packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2470-2025·2025-09-03
Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2464-2025·2025-09-03
Heart and vascular packs recalled because sterilization rationale was not justified
American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2344-2025·2025-08-27
OtoLase starter kits recalled over potentially unsterilized product labeled as sterile
OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Category
Medical Device
Distribution
2 states