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American Medical Systems

American Medical Systems Recalls

All product recalls associated with American Medical Systems.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

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 33221–33240 of 37665 recalls

American Medical Systems: AMS In-Fast Ultra Kit with Polypropylene Suture, REF 7240...

Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.

FDAJan 28, 2008Nationwide• American Medical Systems

Stryker Howmedica Osteonics Corp.: Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-...

Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

FDAJan 25, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Biogenex Laboratories: Xmatrx FISH (fluorescent in situ hybridization) Automated...

Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals.

1...1660 166116621663 1664...1884

Page 1662 of 1884Next

FDAJan 24, 2008Nationwide• Biogenex Laboratories

California Medical Laboratories Inc: CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Si...

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

FDAJan 24, 2008Nationwide• California Medical Laboratories Inc

California Medical Laboratories Inc: CalMed Malleable Pericardial Sump, Single Use Only. Do No...

Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

FDAJan 24, 2008Nationwide• California Medical Laboratories Inc

Wooden Blocks and Train Sets (First Learning) – lead paint violation (2008)

The Big Wooden Blocks contain 30 or 60 colorful block pieces in 11 geometric shapes. The Jumbo Wooden Train Sets contain 70 wooden pieces including trees, stop and railroad crossing signs, a red wooden engine and green train cars. The following style numbers and UPC numbers are printed on the packaging of the toys: Toy Description Style # UPC # Big Wooden Learning Blocks - 30 pieces 7210 14559211 Big Wooden Learning Blocks - 60 pieces 7211 14559235 70-piece Jumbo Wooden Train Sets 13275A 14217340

CPSCJan 24, 2008Nationwide• First Learning Company Ltd., of Hong Kong

Serene Float Tanks (Brian Smith) – electrocution hazard (2008)

Laceration Risk

This recall involves Serene Float Tanks, a water tank that is light- and soundproof, temperature insulated and ventilated. The heated tanks are filled with water and a dissolvent that allows a person to float effortlessly.

CPSCJan 24, 2008Nationwide• Brian Smith, dba Serene Float Tanks, of Lakewood, Calif.

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.

Cybernet Systems Corp.: Cybernet Medical MedStar Telemedicine System, Manufacture...

A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.

FDAJan 23, 2008Nationwide• Cybernet Systems Corp.

Toy Racing Cars (OKK Trading) – lead paint violation (2008)

This recall involves toy racing cars that are operated with a remote control. The toy racing car comes with four additional tires and one remote control. "Formula 1" is printed on the packaging.

CPSCJan 23, 2008Nationwide• OKK Trading Inc., of Commerce, Calif.

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.

Abbott Laboratories: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; L...

Laceration Risk

Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

FDAJan 21, 2008PR• Abbott Laboratories

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.

FDAJan 21, 2008Nationwide• 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.