Manufacturer

Stryker Corporation

88 recalls in our database name Stryker Corporation as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–88 of 88

HighFDA (Devices)·Z-2598-2023·2023-09-27
Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble
Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into the surgical site.
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2463-2023·2023-09-06
SurgiCount+ Surgical Sponge Counting Software Miscounting Recalled
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Product
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1474-2023·2023-05-10
SafeLight Fiber Optic Cable Recall Due to Assembly Defect
Stryker Corporation is recalling SafeLight Fiber Optic Cables due to insufficient epoxy on the proximal end, which can cause light output failure and potentially delay surgical procedures.
Product
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1340-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery
Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2023·2023-04-12
Stryker Tourniquet Cuff May Fail to Hold Pressure During Surgery
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or hold pressure during initial surgical setup. This failure could allow blood to flow from the surgical site, potentially causing hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1344-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2023·2023-04-12
Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure
Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2023·2023-04-12
Stryker Color Cuff Tourniquet Cuff pressure failure recall
Stryker is recalling 1,730 units of Color Cuff Non-Sterile Tourniquet Cuffs due to failures in achieving and maintaining pressure during setup, which could result in operative site blood loss or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss
Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1184-2023·2023-03-08
Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement
Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2023·2023-03-08
Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates
Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.
Product
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1185-2023·2023-03-08
Medivac Guardian blood loss estimation device inserts may provide inaccurate readings
Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2022·2022-03-16
Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
Product
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
Category
Medical Device
Distribution
Distributed nationwide