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All product recalls associated with Abiomed, Inc..
Total Recalls
1000
Past Year
1000
Class I (Serious)
127
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.
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).
This recall involves Avocado-branded Organic Cotton Mattress Pad Protectors sold in sizes Twin, Twin XL, Full, Queen, King and California King. All sizes were sold in both a Standard Pocket and Deep Pocket version. The quilted, ivory-color mattress pads are made of cotton ticking and cotton fiber fill. Attached to the mattress pad is a law label listing "Model SFMPAVORG", manufacturer name, date of delivery, date of manufacture, fiber content, and washing instructions.
This recall involves the Origin 21 oval and rectangle wall mirrors. These mirrors were sold in black metal frames. The rectangle mirror measures 22 inches wide and 31 inches long, with model number L1-MH-1647. The oval mirror measures 24 inches wide and 36 inches long, with model number L1-MH-1693. The model numbers are printed on a label affixed to the back of the mirror.
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Failed Dissolution Specifications: below specification results
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Potential for the front lever chain of the DR 800 table to fail.
MAMTAKIM Inc.,888 Magnolia Ave, Elizabeth NJ 07201 is initiating a recall of Scortisoara macinata/ Ground cinnamon, 15 g, Paper cartons, 20 pieces per paper carton, Code: 10C035 because the ground cinnamon product contain elevated levels of lead .
Undeclared peanuts (allergen)
This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
This recall involves 2024 Mule PRO-FX™ 1000, PRO-FXR™1000 and PRO-FXT™ 1000 utility vehicles. The four wheel, off-highway utility vehicles were sold in Metallic Sierra Blue, Metallic Onyx Black, Firecracker Red, Ice Gray, TRUETIMBER® Strata, Metallic Titanium, and Metallic Stardust White colors. The Vehicle Identification Number (VIN) is located on the forward frame rail below the seat. The model name and model code are printed on the owner's manual. Model Numbers Model Name VIN UPC / Date Codes Assembly Date Retail Price KAT1000ARFNN / ARFNL MULE PRO-FXT 1000 LE JKAATCA12RB500001 5/10/2023 18799 KAF1000LRFNN/LRFNL MULE PRO-FX 1000 HD Edition JKAAFCL17RB500001 5/16/2023 16799 KAF1000MRFNN/MRFNL MULE PRO-FXR 1000 JKAAFCM19RB500001 5/23/2023 15099 KAF1000NRFNN/NRFNL MULE PRO-FXR 1000 LE JKAAFCN10RB500001 5/23/2023 16199 KAT1000BRFNN/BRFNL MULE PRO-FXT 1000 LE Camo JKAATCB14RB500001 5/10/2023 18899 KAT1000CRFNN/CRFNL MULE PRO-FXT 1000 LE Ranch Edition JKAATCC16RB500001 5/9/2023 20399 KAT1000DRFNN/DRFNL MULE PRO-FXT 1000 Platinum Ranch Edition JKAATCD18RB500001 5/9/2023 21899
This recall involves Brooke model chairs including: all wood dining chairs in several styles, including partially and fully upholstered seats, and fully upholstered seat and back. The model numbers W520, W520-11, W520-21, W520-31, and W520-33 can be found on the original order confirmation or invoice. If not available, reference the Special Order Number ("SO#") found on the white sticker on the underside of each chair. A list of affected special order numbers can be found at www.grandrapidschair.com/customer-service/product-safety-recall-brooke/.
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Product has have presence of brown discoloration or substance on the hinge area of the device
Presence of Particulate Matter
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".