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B & K Medical Systems, Inc.

B & K Medical Systems, Inc. Recalls

All product recalls associated with B & K Medical Systems, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 18221–18240 of 21320 recalls

B & K Medical Systems, Inc.: B-K Medical Intraoperative Transducer Type 8814, diagnost...

Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

FDAJan 24, 2008MA, MI, OR +2 more• B & K Medical Systems, Inc.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Solid BK Acetabular Shells; 42mm to...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposite...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDA

1...910 911912913 914...1066

Page 912 of 1066Next

Jan 21, 2008

Nationwide

• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Multi Arc Deposited; Hydroxylapat...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident PSL HA Cluster: 40 mm to 72 mm, hip prosthesis c...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical HA Cluster, 42 mm - 74mm Arc Depos...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident Hemispherical Acetabular Shells HA Solid BK 42mm...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident PSL Acetabular Shells; Trident PSL HA Solid Back...

Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

FDAJan 21, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Radiometer America Inc: ABL700 Series analyzer - Human Blood Analyzer (Laboratory...

Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.

FDAJan 18, 2008IN• Radiometer America Inc

Otsuka America Pharmaceutical, Inc.: UBiT-IR300 Infrared Spectrophotometer, Software Versions ...

Medical device power supply may overheat and cause smoke to be emitted from the device.

FDAJan 18, 2008Nationwide• Otsuka America Pharmaceutical, Inc.

Radiometer America Inc: ABL800 FLEX Series Analyzer - Human Blood Analyzer (Labor...

FDAJan 18, 2008IN• Radiometer America Inc

Jar Candles (Wick & Petal) – fire hazard (2008)

Fire/Burn Risk

This recall involves all Wick & Petal jar candles. The candles have a cylindrical shape and a chrome lid. The lid has a white label with a picture of the fragrance, the fragrance name, and "Wick & Petal Co." printed on it.

CPSCJan 17, 2008Nationwide• The Wick & Petal Co. of Indianapolis, Ind.

Cooper Surgical, Inc.: M-Style Cup with Universal Vacuum Release (UVR) used with...

Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.

FDAJan 16, 2008Nationwide• Cooper Surgical, Inc.

Medtronic Neuromodulation: Medtronic IsoMed Implantable Constant-Flow Infusion Pump,...

Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d

FDAJan 16, 2008WA, PR• Medtronic Neuromodulation

Cooper Surgical, Inc.: Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery S...

FDAJan 16, 2008Nationwide• Cooper Surgical, Inc.

Civco Medical Instruments Inc: CIVCO Latex-Free Needle Guide, Sterile transrectal needle...

Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).

FDAJan 16, 2008Nationwide• Civco Medical Instruments Inc

St Jude Medical CRMD: Implantable Cardioverter Defibrillator EPIC VR Tiered-th...

A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.

FDAJan 16, 2008Nationwide• St Jude Medical CRMD

Cooper Surgical, Inc.: M-Style Mushroom Cup Vacuum Assisted Delivery System use...

FDAJan 16, 2008Nationwide• Cooper Surgical, Inc.

Medtronic Neuromodulation: Medtronic - SynchroMed EL Implantable Infusion Pump, Mode...

FDAJan 16, 2008WA, PR• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic SynchroMed II Programmable Pump, model 8637-20....

FDAJan 16, 2008WA, PR• Medtronic Neuromodulation