Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Sysmex America, Inc.

Sysmex America, Inc. Recalls

All product recalls associated with Sysmex America, Inc..

Get alerts for this brand

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 17241–17260 of 21320 recalls

Sysmex America, Inc.: Sysmex Stromatolyser-IM; a lytic reagent for use with the...

The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.

FDAJun 23, 2009Nationwide• Sysmex America, Inc.

GE OEC Medical Systems, Inc: OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); I...

GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.

Class IHigh

FDAJun 22, 2009Nationwide• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); I...

1...861 862863864 865...1066

Page 863 of 1066Next

FDAJun 22, 2009Nationwide• GE OEC Medical Systems, Inc

Remington Medical Inc.: Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM,...

Two unsealed pouches were identified after product release, compromising product sterility.

FDAJun 19, 2009CA, WI• Remington Medical Inc.

Stryker Howmedica Osteonics Corp.: V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-...

Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

FDAJun 18, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Generic Medical Devices: GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product...

Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.

FDAJun 18, 2009NJ, PA• Generic Medical Devices

Stryker Howmedica Osteonics Corp.: Dall Miles Cable Grip System; Catalog number 6704-0-210; ...

Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

FDAJun 18, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Ascension Orthopedics, Inc: Ascension PyroCarbon PIP Total Joint - Trials; Ascension...

Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.

FDAJun 17, 2009Nationwide• Ascension Orthopedics, Inc

Boston Scientific Corporation: Boston Scientific Clipping Device, Resolution Clip, work...

The clip may not deploy or, if deployed, the clip may not release from the tissue.

FDAJun 17, 2009Nationwide• Boston Scientific Corporation

Siemens Healthcare Diagnostics, Inc.: Dimension Vista System BUN Flex Reagent Cartridge, Catalo...

Incorrect result: patient sample BUN results reported may be higher or lower than actual level.

FDAJun 16, 2009Nationwide• Siemens Healthcare Diagnostics, Inc.

St. Jude Medical Atrial Fibrillation Division Inc: St. Jude Medical Epicor UltraWand LP Handheld Ablation De...

The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has

FDAJun 15, 2009AL, AZ, CA +33 more• St. Jude Medical Atrial Fibrillation Division Inc

Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release...

Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.

FDAJun 12, 2009Nationwide• Computerized Medical Systems Inc

Becton Dickinson and Company: BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. B...

Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.

FDAJun 12, 2009Nationwide• Becton Dickinson and Company

Toaster Ovens (Wolfgang Puck) – electrical issue (2009)

Fire/Burn Risk

The recalled toasters have model #WPTOT010 with date codes 3608, 3908, 0407, 0607, or 0807 or model # BTOT0010 with date code 0207. The model numbers and date codes are located on an Underwriters Laboratories (UL) label, which is affixed to the back of the unit. The black and stainless steel toasters have "Wolfgang Puck" or "Wolfgang Puck Bistro Collection" stamped on the lower front right corner. They feature a stainless steel handle on the oven door, three black knobs for controlling cooking, and a black push-down lever for toasting. Two slots for toasting bread and similar products are located on the top of the toaster.

CPSCJun 12, 2009Nationwide• Kingpower Electrical Appliances of China

Roche Diagnostics Corp.: Roche ACCU-CHEK Performa blood glucose test strips, Roche...

There may be a significant negative bias when testing neonate samples.

FDAJun 10, 2009Nationwide• Roche Diagnostics Corp.

Advanced Bionics LLC: Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-14...

The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas

FDAJun 10, 2009Nationwide• Advanced Bionics LLC

Stryker Howmedica Osteonics Corp.: Trident Acetabular System Surgical Protocol. Instruction...

The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.

FDAJun 9, 2009Nationwide• Stryker Howmedica Osteonics Corp.

GE Medical Systems, LLC: GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/...

Breathing circuit inner tube may separate from the rigid connectors under certain conditions. A separation of the inner tube from the connector may prevent adequate gas flow (O2, N2O and anesthetic agents) to the patient. A separation can also cause CO2 re-breathing. This could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.

FDAJun 5, 2009Nationwide• GE Medical Systems, LLC

Trek Diagnostic Systems: Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB ...

Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.

FDAJun 4, 2009Nationwide• Trek Diagnostic Systems

Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa: Applied Medical 15x100mm Kii Optical Access System, Non-T...

Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.

FDAJun 4, 2009Nationwide• Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa