Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm…
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport…
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- Synapse Biomedical
- Product
- NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm…
- Classification
- Class III
- Units
- Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Synapse Biomedical recalls
- 2022-08-31
USSynapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and…
FDA · DeviceSynapse Biomedical Incdistribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-27
- US
Stryker Instruments Div. of Stryker Corporation recalls Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters)…
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in…
- US
Surgical Innovations Ltd recalls YelloPort Elite Universal Seal. For use in laparoscopic procedures.
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
FDA · DeviceSurgical Innovations LtdWorldwide distribution - US Nationwide distribution in the states of FL, IN,…Official notice → - US
Stryker Instruments Div. of Stryker Corporation recalls Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
- US
Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and…
FDA · DeviceBoston Scientific CorporationDomestic distribution to AR CA IL ME MI NC TX Foreign distribution to…Official notice → - US
Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic…
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA,…Official notice → - US
R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body…
FDA · DeviceR & D Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of FL, MN,…Official notice →