Hazard

Surgical Device Defect recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2026-08-12

Of the 9 surgical device defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 device defect 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.

1–9 of 9

HighFDA (Devices)·Z-2885-2026·2026-08-12
U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2025·2025-02-05
Medtronic Percutaneous Reference Pins May Not Fit Properly
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.
Product
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1470-2024·2024-04-10
Covidien Auto Suture Blunt Tip Trocar Seal Disengagement Recall
Covidien Auto Suture Blunt Tip Trocar units may experience seal disengagement when mesh products are used incorrectly with the device. Healthcare facilities should discontinue use of affected units and contact Covidien for guidance.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2023·2023-05-03
Surgical Convenience Kits Recalled Due to Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2023·2023-04-26
Surgical Centurion CirClamp Recalled for Incorrect Subassembly Size
Medline Industries is recalling 162 units of Centurion CirClamp surgical devices due to incorrect subassembly size. The defect could affect proper device function during surgical use.
Product
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1386-2023·2023-04-19
Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking
Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0290-2023·2022-11-30
Eye Surgery Convenience Kits Recalled for Containing Recalled 3M Drapes
ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.
Product
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0303-2023·2022-11-30
Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes
ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.
Product
¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0034-2022·2021-10-13
Flower E-Kit bone fixation kits recalled due to missing surgical component
Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.
Product
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Category
Medical Device
Distribution
Distributed nationwide